burrs

Catalog No. (UDI-DI): MBUR5060FRCV (00821925036529), MBUR6060FRCV (00821925036536), and MBUR7060FRCV (00821925036543) ALL LOTS MANUFACTURED BEFORE AUGUST 3, 2017

Ear, Nose, and Throat Devices

1

No

NM, MI, and TX EU, Australia, Japan, and Hong Kong

Gyrus ACMI Round Cutting Burrs - to be used with the Diego Elite system

General and Plastic Surgery Devices

1

No

AL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, MA, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, WA, WI, and WV OUS: CANADA

Burrs || Model #'s: || ANSL-3SB || ANSL-5D || ANSQD11-4OVDC || HAL5056-118 || HAL5056-166 || HAL5091-106 || HAL5091-112 || HAL5091-122 || HAL5091-125 || HAL5091-136 || HAL5091-144 || HAL5091-164 || HAL5092-120 || HAL5092-168 || HAL5092-170 || KOM04-D0139 || LIN5091-101 || LIN5091-102 || LIN5091-142 || LIN5092-132 || LIN5092-160 || MED874-447 || MICZB-228 || MICZB-232 || MID14CY50 || MID14MH30D || MIDG6-450 || MIDG8-130 || MIDMC254 || STR1607-2-35 || STR1608-6-137 || STR1608-6-141 || STR1608-6-149 || STR277-10-62 || STR5120-10-40 || STR5120-10-50 || STR5120-71-48 || STR5300-10-511 || STR5300-10-513 || STR5300-10-903 || STR5300-20-513 || STR5300-30-903 || XOM31-55641 || ZIM5056-116 || ZIM5056-117 || ZIM5056-118 || ZIM5056-125 || ZIM5056-140 || ZIM5056-150 || ZIM5056-159 || ZIM5056-161 || ZIM5056-162 || ZIM5056-164 and || ZIM5056-167 || Surgical instruments motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue.

Batch # - C323023789

Neurological Devices

2

No

Worldwide Distribution--USA (nationwide) including the states of Alabama, California, and Wisconsin and the countries of Columbia, France, Germany, Great Britain, Italy, Panama, Poland, Saudi Arabia, South Africa, Spain, and Switzerland.

Sterile Bone Cutting Burrs model IMRI-S-8NS-M labeled in part:***IMRI-S-8NS-M***QTY: 1***3 mm Fluted Matchstick, Extends 8.9 mm,***Less Aggressive. Use with IMRI-SHORT***Attachments.***Use by 2014 08***ANSPACH***Manufacturer***Made in USA***The Anspach Effort, Inc.***4500 Riverside Drive***Palm Beach Gardens, FL 33410, USA***Tel: (800) 327 6887 / + 1 561 627 1080***EC REP***Anspach Europe Ltd.***Aston Court, Kingsmead Business Park***Frederick Place***High Wycombe, HP 11 1LA***United Kingdom***Tel: +441494 616126***Rx Only***LOT C323023789***. || Cutting and Shaping bone including bones of the spine and cranium.

Batch #s - D153034013, D173034385

Neurological Devices

2

No

Worldwide Distribution--USA (nationwide) including the states of Alabama, California, and Wisconsin and the countries of Columbia, France, Germany, Great Britain, Italy, Panama, Poland, Saudi Arabia, South Africa, Spain, and Switzerland.

Sterile Bone Cutting Burrs model S-5B-4 labeled in part:***S-5B-4***QTY: 1***5 mm Fluted Ball, 4-Series.***Use with***SHORT Attachments.***Use by 2016-03***ANSPACH***Manufacturer***Made in USA***The Anspach Effort, Inc.***4500 Riverside Drive***Palm Beach Gardens, FL 33410, USA***Tel: (800) 327 6887 / + 1 561 627 1080***EC REP***Anspach Europe Ltd.***Aston Court, Kingsmead Business Park***Frederick Place***High Wycombe, HP 11 1LA***United Kingdom***Tel: +441494 616126***Rx Only***LOT E173049623***. || Cutting and Shaping bone including bones of the spine and cranium.

Batch # - C403026551

Neurological Devices

2

No

Worldwide Distribution--USA (nationwide) including the states of Alabama, California, and Wisconsin and the countries of Columbia, France, Germany, Great Britain, Italy, Panama, Poland, Saudi Arabia, South Africa, Spain, and Switzerland.

Sterile Bone Cutting Burrs model M-6P labeled in part:***M-6P***QTY: 1***6 mm x 9 mm Fluted Pear.***Use with*** MEDIUM Attachments.***Use by 2015-12***ANSPACH***Manufacturer***Made in USA***The Anspach Effort, Inc.***4500 Riverside Drive***Palm Beach Gardens, FL 33410, USA***Tel: (800) 327 6887 / + 1 561 627 1080***EC REP***Anspach Europe Ltd.***Aston Court, Kingsmead Business Park***Frederick Place***High Wycombe, HP 11 1LA***United Kingdom***Tel: +441494 616126***Rx Only***LOT D493042603***. || Cutting and Shaping bone including bones of the spine and cranium.