All products in the Lava Ultimate product family.

Dental Devices

2

No

Worldwide Distribution - US: Nationwide and the countries of: Australia, India, Japan, Korea, New Zealand, Singapore, Thailand, Vietnam, Canada, Bulgaria, Czech Republic, Estonia, Hungary, Israel, Latvia, Lithuania, Poland, Romania, Slovakia, Switzerland, Turkey, China Hong Kong, Taiwan, Brazil, Colombia, Costa Rica, Guatemala, Mexico, Egypt, Morocco, South Africa, Austria, Belgium, Denmark, Finland, France, Germany, Greece, Italy, Netherlands Norway, Portugal, Spain, Sweden, UK and Ireland.

Block Versions Used by Dental Offices often referred to as chairside milling: || Lava Ultimate Restorative for CEREC, Compatible with Sirona mill 2912x, 2914x, 3312x, 3314x. || Lava Ultimate Restorative for E4D Compatible with E4D mills, same mandrel format as Planmill 3112x, 3114x, 4012x, 4014x. || Lava Ultimate for Straumann milling centers 1334x. || Lava Ultimate CAD/CAM Restorative for TS150, Compatible with TS150 (IOS Technologies), Glidewell Laboratories, 2614x. || Lava Ultimate Restorative with Blue Mandrel, Pedestal Mandrel, compatible with Carestream CS 3000, Roland DWX-50, Roland DWX-4, 1314x, 2012x, 2110x. || Lava Ultimate Restorative for Planmill, Compatible with Planmill mills, same mandrel format as E4D, 4212x, 4214x, 4312x, 4414x, 5072x, 5074x. || Lava Ultimate Restorative for Ceramill, Compatible with Ceramill mills manufactured by Amann Girrbach, 4514x, 4714x, 5044x. || Frame/Blank Version Used by Dental Laboratories: || Lava Ultimate Implant Crown Restorative, Compatible with Lava Milling Equipment (Lava blocks bonded into frames. These are also known as blanks.), 69140-69149, 69150-69159, 69160-69163.

Catalog# 1581, lot # 2020-10AN Catalog# 2081, lot # 2018-AM (shipper carton)

General Hospital and Personal Use Devices

1

No

US nationwide distribution.

3M Coban Self-Adherent Wrap Shipper carton label identified the product as 3M Coban LF Latex Free Catalog #2081, lot number 2018-10AM.

Model 5XL, Serial Numbers: 722612 - 722683, 820352 - 820360  Model 8XL, Serial Numbers: 351303 - 351399, 450144 - 450147

General Hospital and Personal Use Devices

2

No

AL, CO, CT, FL, GA, IN, NC, NJ, NY, OK, OR, PA, RI, VA, WI, and OUS to include: Argentina, Canada, Chile, China, Columbia, El Salvador, Germany, India, Indonesia, Japan, Korea, Mexico, Peru, Philippines, South Africa, Switzerland, Thailand, Trinidad, Turkey, United Arab Emirates, Vietnam.

3M Steri-Vac Gas Sterilizer/Aerator, models 5XL and 8XL.

Serial Number: 100873

General Hospital and Personal Use Devices

1

No

U.S. Distribution: TX only

3M Ranger(TM) Pressure Infusor, Model 145, SKU 70200792979 || The 3M Ranger Pressure Infusor is a hardware device intended to provide pressure to I.V. solution bags when rapid infusion of liquids is required.

(a) Cat #901014, Lot Numbers: 7223T2, 7133C2, 7144E2, 7332I2 (b) Cat #901015, Lot Number 7223U2

General and Plastic Surgery Devices

1

No

AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MD, MI, MO, MS, NC, NH, NY, OH, OR, PA, SC, TN, TX, UT, VA, WI, WV

ACE(TM) BRAND, ULTRA LITE ANKLE brace: (a) Size Selection Medium, Cat #901014, UPC 051131019984 2; (b) Size Selection Large, Cat #901015, UPC 0 51131019985 9

Lot Numbers: R10359, R10360, R10361, R10362, R10363, R10364, R10365, R10366

Cardiovascular Devices

2

No

Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, Chile, Costa Rica, Deutschland GMBH, Dominican, Ecuador, Hong Kong, Indonesia, Japan, Korea, Paraguay, Philippines, New Zealand, Shanghai, Thailand, and Uruguay.

3M Bair Hugger(M) Normothermia System, Full Access Underbody Warming Blanket, REF 63500 || The 3M Bair Hugger Temperature Management System is intended to prevent and treat hypothermia. In addition, the temperature management system can be used to provide patient thermal comfort when conditions exist that may cause patients to become too warm or too cold. The temperature management system can be used with adult and pediatric patients.

Lot Numbers: FR10361

Cardiovascular Devices

2

No

Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, Chile, Costa Rica, Deutschland GMBH, Dominican, Ecuador, Hong Kong, Indonesia, Japan, Korea, Paraguay, Philippines, New Zealand, Shanghai, Thailand, and Uruguay.

3M Bair Hugger(M) Normothermia System, Sterile Full Access Underbody, Model 63700 || The 3M Bair Hugger Temperature Management System is intended to prevent and treat hypothermia. In addition, the temperature management system can be used to provide patient thermal comfort when conditions exist that may cause patients to become too warm or too cold. The temperature management system can be used with adult and pediatric patients.

All lots

Physical Medicine Devices

1

No

US and Australia, Jordan, Republic Of Korea, Lebanon, New Zealand, Oman, Qatar, Taiwan, United Arab Emirates

FUTURO (TM) SPORT, QUICK STRAP ANKLE SUPPORT, REF 47736GEN, UPC 0 51131 19692 6

All lots

Physical Medicine Devices

1

No

US and Australia, Jordan, Republic Of Korea, Lebanon, New Zealand, Oman, Qatar, Taiwan, United Arab Emirates

ACE (TM) BRAND, DELUXE ANKLE BRACE, 207736, UPC 0 51131 20387 7

all

General and Plastic Surgery Devices

1

No

Worldwide distribution including US nationwide, including Puerto Rico. Singapore, Australia, Canada, Chile, Colombia, Costa Rica, Brazil, Dominica, Ecuador, Guatemala, UAE, Israel, Japan, Korea, Mexico, new Zealand, Paraguay, Peru, Taiwan, Uruguay, India, Bolivia, El Salvador, Saudi Arabia, and Thailand.

3M Surgical Clipper Professional 9681

IMPRINT™ II Regular Body VPS Impression Material Refill 4-PACK Catalog Number 9379, Lot Codes N510884 and N510889 PARADIGM™ Regular Body VPS Impression Material Refill 2-PACK Catalog Number 5315, Lot Code N511952

Crown and bridge impressions, Inlay and onlay impressions, Functional impressions, Denture and partial denture impressions

Models 5XL and 8XL.

Gas Sterilizer/Aerator

Lot Number:03122011-A Expiry Date:3-12-2013

Surgical Drapes

Model No. 36000; Lot Nos.: 17230, 17233, 17234, 17241 Formerly known as SpotOn Temperature Monitoring Sensors

Monitors, Physiologic, Temperature

Model No. 36000; Lot Nos.: 17230, 17233, 17234, 17241 Formerly known as SpotOn Temperature Monitoring Sensors

Monitors, Physiologic, Temperature

Model 24355 Lot Numbers: HX 7223 and HX 7270

fluid warming system

1) 3MTM Bair Hugger™ Full Access Underbody Warming Blanket 63500 Lot Nos.: R10359, R10360, R10361, R10362, R10363, R10364, R10365, R10366 2) 3MTM Bair Hugger™ Full Access Underbody Warming Blanket 63700 Lot Nos.: FR10361

Warming Units, Patient, Forced-Air

Product Code 902150 (Kit) • Lot Codes N484233 and N463186 Product Code 900224 (Refill) • Lot codes N466509 and N473723

Dental product, Unitek™ Primary ,Stainless Steel Crowns - Series UR4

3M Steri-Drape™ Surgical Drape Packs and 3M Gown

Surgical Drapes