Lot 6944785

General and Plastic Surgery Devices

Unclassified

Yes

Worldwide Distribution - US Nationwide and the countries of: Germany, UK, and Belgium

Artoura Breast Tissue Expander 700 cc || Product Usage: || Tissue expanders can be used for breast reconstruction after mastectomy, correction of an underdeveloped breast, scar revision and tissue defect procedures. The devices are intended for temporary subcutaneous or sub muscular implantation and are not intended for use beyond six months.

Lot 6947019

General and Plastic Surgery Devices

Unclassified

Yes

Worldwide Distribution - US Nationwide and the countries of: Germany, UK, and Belgium

CPX4 Breast Tissue Expander 650 cc || : || Product Usage: Tissue expanders can be used for breast reconstruction after mastectomy, correction of an underdeveloped breast, scar revision and tissue defect procedures. The devices are intended for temporary subcutaneous or sub muscular implantation and are not intended for use beyond six months.

Part Number 800-1212 lot # 1038452.

Orthopedic Devices

Unclassified

Yes

Nationwide Distribution including PA, TX, CA, IL IA, FL, CT, and MO

OSTEOMED SPINE Facet Fixation System PrimaLOK FF Threaded Implant Driver Shaft OsteoMed L.P. 3885 Arapaho Road, Addison, Texas 75001

All lot numbers associated with the identified part numbers.

General and Plastic Surgery Devices

Unclassified

Yes

Worldwide Distribution -- US, including Washington, DC and states of AK, AZ, CA, CT, FL, GA, ID, KS, LA, MD, MA, MI, MN, MO, NE, NH, NY, NC, OH, OR, PA, SC, TX, VA, WA, and WI, and the country of Canada.

Synthes(R) Hemostatic Bone Putty, Part numbers 08.901.001.97S, 08.901.001.98S, 08.901.001.99S, 08.901.001D, and VB1025.10S. || Indicated for use as a water soluble implant material and for use in the control of bleeding from bone surfaces.

Model / Lot #: SP78100 / 114149, SP78105 / 114219.

Ear, Nose, and Throat Devices

Unclassified

Yes

Nationwide Distribution in the states of CA, CT, DE, FL, GA, ID, IL, IN, MD, MA, MI, MN, NJ, NY, NC, PA, TX, UT, and WI. FRANCE, NETHERLANDS, BELGIUM, UNITED KINGDOM, CANADA, ISRAEL, PERU, SPAIN, IRELAND.

SP78100, SP78105 || Nasal Products, Catalog Number SP-78100, Nasal Septal Button Standard (3cm), Rx Only, Sterilized by Ethylene Oxide, Micromedics Inc., St Paul, MN 55121-1385. || Nasal Products, Catalog Number SP-78105, Nasal Septal Button Oversize (5cm), Rx Only, Sterilized by Ethylene Oxide, Micromedics Inc., St Paul, MN 55121-1385.

CATALOG NO. 9045-01, LOT #'s: 050709-8, 050809-C, 051209-D, 060209-A, 060809-C, 061709-C, 062009-0,  CATALOG NO. 9045-02, LOT #'s: 050809-B, 051309-8,060809-8, 061 709-0,060209-A

Orthopedic Devices

Unclassified

Yes

Nationwide Distribution including CO, CT, FL, KY, LA, MA, MO, NC, NY, OK, OR, TN, TX, VA & WI

PERPOS PLS, CATALOG #'s 9045-01 & 9045-02 || A sterile, medical device kit consisting of the components listed in Table 1-1 below. The kit is used by medical professionals to stabilize the spine as an aid to fusion through immobilization of the facet joints.

CATALOG NO. 9045-01, LOT #'s: 050709-8, 050809-C, 051209-D, 060209-A, 060809-C, 061709-C, 062009-0,  CATALOG NO. 9045-02, LOT #'s: 050809-B, 051309-8,060809-8, 061 709-0,060209-A

Orthopedic Devices

Unclassified

Yes

Nationwide Distribution including CO, CT, FL, KY, LA, MA, MO, NC, NY, OK, OR, TN, TX, VA & WI

Catalog # 9024-00 or LSW-S-3040 for 4.5mm BONE-LOK PLS Implant || A sterile, canulated screw that is supplied as a stand-alone product. The 4.5mm BONE-LOK PLS Implant is also supplied as a component of the Single Use PERPOS PLS System (9045-01 and 9045-02). The labeling and instructions for use for the 4.5mm BONE-LOK PLS a Implant (9024-00) are provided in Appendix C.

All manuals; the manual were not coded.

Orthopedic Devices

Unclassified

Yes

Nationwide

Satellite Spinal System Primary User Group Reference Guide, 8 1/2 by 11 inch plastic binder, Medtronic Sofamor Danek, Medtronic, Memphis, TN 38132

All (US versions) guides/techniques; The Surgical Technique and Manual are not coded

Orthopedic Devices

Unclassified

Yes

Nationwide

Satellite Spinal System Surgical Technique, LITSATFUSST7-IRN10612/087, and LIT (DRAFT) Medtronic, Spinal and Biologics Business, Memphis, TN (this guide was originally a portion of the Satellite Spinal System Primary User Group Reference Guide a 8 1/2 by 11 inch plastic binder)

ALL LOTS to include: W05K0556, W05K1614, W06A3260

Orthopedic Devices

Unclassified

Yes

Nationwide

Medtronic Sofamor Danek, 9 mm Satellite Sphere CoCr, Size 9 mm, Quantity 1 each, Material Cobalt Chrome, Sterile, Rx only, REF 8000209, Manufactured at: Warsaw, Indiana, USA

ALL LOTS to include: W05K0134, W05K0543, W05K0560, W05K0565, W05K1572, W05K1573, W05K1575

Orthopedic Devices

Unclassified

Yes

Nationwide

Medtronic Sofamor Danek, 10 mm Satellite Sphere CoCr, Size 10 mm, Quantity 1 each, Material Cobalt Chrome, Sterile, Rx only, REF 8000210, Manufactured at: Warsaw, Indiana, USA

ALL LOTS to include: W05K0144, W05K0552, W05K0553, W05K0554, W05K0567, W05K0572, W05K0722

Orthopedic Devices

Unclassified

Yes

Nationwide

Medtronic Sofamor Danek, 11 mm Satellite Sphere CoCr, Size 11 mm, Quantity 1 each, Material Cobalt Chrome, Sterile, Rx only, REF 8000211, Manufactured at: Warsaw, Indiana, USA

ALL LOTS to include: W05K0541, W05K0542, W05K0550, W05K0551, W05K0558, W05K0731, W06A0842

Orthopedic Devices

Unclassified

Yes

Nationwide

Medtronic Sofamor Danek, 12 mm Satellite Sphere CoCr, Size 12 mm, Quantity 1 each, Material Cobalt Chrome, Sterile, Rx only, REF 8000212, Manufactured at: Warsaw, Indiana, USA

ALL LOTS to include: W05K0132, W05K0557, W05K1576, W05K1595, W05K2449, W06A0915

Orthopedic Devices

Unclassified

Yes

Nationwide

Medtronic Sofamor Danek, 13 mm Satellite Sphere CoCr, Size 13 mm, Quantity 1 each, Material Cobalt Chrome, Sterile, Rx only, REF 8000213, Manufactured at: Warsaw, Indiana, USA

ALL LOTS to include: W05K0561, W05K0582, W05K1920, W06A2074, W07H0210

Orthopedic Devices

Unclassified

Yes

Nationwide

Medtronic Sofamor Danek, 14 mm Satellite Sphere CoCr, Size 14 mm, Quantity 1 each, Material Cobalt Chrome, Sterile, Rx only, REF 8000214, Manufactured at: Warsaw, Indiana, USA

ALL LOTS to include: W05K0562, W05K0566, W05K1593, W06A2809

Orthopedic Devices

Unclassified

Yes

Nationwide

Medtronic Sofamor Danek, 15 mm Satellite Sphere CoCr, Size 15 mm, Quantity 1 each, Material Cobalt Chrome, Sterile, Rx only, REF 8000215, Manufactured at: Warsaw, Indiana, USA

ALL LOTS to include: W05K0135, W05K0564, W05K1016, W06A1100

Orthopedic Devices

Unclassified

Yes

Nationwide

Medtronic Sofamor Danek, 16 mm Satellite Sphere CoCr, Size 16 mm, Quantity 1 each, Material Cobalt Chrome, Sterile, Rx only, REF 800021, Manufactured at: Warsaw, Indiana, USA

ALL LOTS to include: LX52, MA67

Orthopedic Devices

Unclassified

Yes

Nationwide

Medtronic Sofamor Danek, Satellite System Sphere PEEK, Size 10 mm, Material PEEK-Optima, quantity 1, Sterile, Rx only, REF 9000210, Manufactured at: Warsaw, Indiana, USA

ALL LOTS to include: LX53, LX59,MG73, MY47, MY49, NC36, ND61, NE27

Orthopedic Devices

Unclassified

Yes

Nationwide

Medtronic Sofamor Danek, Satellite System Sphere PEEK, Size 11 mm, Material PEEK-Optima, quantity 1, Sterile, Rx only, REF 9000211, Manufactured at: Warsaw, Indiana, USA

ALL LOTS to include: LX54, LX60, MA68, MG74, NB26, NE28, NF61

Orthopedic Devices

Unclassified

Yes

Nationwide

Medtronic Sofamor Danek, Satellite System Sphere PEEK, Size 12 mm, Material PEEK-Optima, quantity 1, Sterile, Rx only, REF 9000212, Manufactured at: Warsaw, Indiana, USA

ALL LOTS to include: LX55, LX61, MA69, MG75, NB27, ND62, NE29, NF62

Orthopedic Devices

Unclassified

Yes

Nationwide

Medtronic Sofamor Danek, Satellite System Sphere PEEK, Size 13 mm, Material PEEK-Optima, quantity 1, Sterile, Rx only, REF 9000213, Manufactured at: Warsaw, Indiana, USA

ALL LOTS to include: LX56, LX62, MA70, MG76, NB28, ND63, NE30

Orthopedic Devices

Unclassified

Yes

Nationwide

Medtronic Sofamor Danek, Satellite System Sphere PEEK, Size 14 mm, Material PEEK-Optima, quantity 1, Sterile, Rx only, REF 9000214, Manufactured at: Warsaw, Indiana, USA

ALL LOTS to include: LX57, LX63, MA71, MG77, NB29, NE31

Orthopedic Devices

Unclassified

Yes

Nationwide

Medtronic Sofamor Danek, Satellite System Sphere PEEK, Size 15 mm, Material PEEK-Optima, quantity 1, Sterile, Rx only, REF 9000215, Manufactured at: Warsaw, Indiana, USA

ALL LOTS to include: LX58, MA72, MA98, MY48, NB30, NE32

Orthopedic Devices

Unclassified

Yes

Nationwide

Medtronic Sofamor Danek, Satellite System Sphere PEEK, Size 16 mm, Material PEEK-Optima, quantity 1, Sterile, Rx only, REF 9000216, Manufactured at: Warsaw, Indiana, USA

Product code: W31; Lot # AG089. W31 is the product code for unfinished product. AG089 is the lot number assigned by Sharp Corp.  DW31B is assigned on the inner box labels.

General and Plastic Surgery Devices

Unclassified

Yes

Nationwide Distribution.

Bone Wax. || Ethicon, Inc. || Bone wax is available sterile in individual foil envelopes, each containing 2.5 grams, and then packaged in an individually sealed over wrap packet. || The device is indicated for use to control bleeding from the bone surface during surgical procedures.