N/A 323.0071

GUDID 00841036272203

BIOMET MICROFIXATION, INC

Surgical instrument handle, non-torque-limiting
Primary Device ID00841036272203
NIH Device Record Key19351ec0-92e9-4370-92d8-92a8c9270226
Commercial Distribution StatusIn Commercial Distribution
Brand NameN/A
Version Model Number323.0071
Catalog Number323.0071
Company DUNS046189866
Company NameBIOMET MICROFIXATION, INC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(904)741-4400
EmailFXJAX-ORDERS@ZIMMERBIOMET.COM

Device Identifiers

Device Issuing AgencyDevice ID
GS100841036272203 [Primary]
GS100854865007335 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPlate, fixation, bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00841036272203]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-10-01
Device Publish Date2019-09-23

On-Brand Devices [N/A]

0084103604840251-1610
0084103604839651-1600
0084103602798809-0229
0084103602792609-0222
0084103602791909-0221
0084103602788909-0217
0084103602786509-0215
0084103602785809-0214
0084103602783409-0212
0084103602773509-0201
0084103620897402-0424
0084103615969602-8426
0084103614876833-0124
0084103613059602-8432
0084103612834012-0010
0084103612783102-8428
0084103608602212-0013
0084103604306333-0125
0084103604302533-0120
0084103604291233-0090
0084103604277633-0054
0084103604148928-0620
0084103603153412-0247
0084103603152712-0245
0084103603151012-0242
0084103603139812-0083
0084103603120612-0050
0084103603119012-0047
0084103603118312-0045
0084103603117612-0042
0084103603116912-0041
0084103603111412-0036
0084103603110712-0035
0084103603095712-0007
0084103603094012-0006
0084103603093312-0005
0084103603092612-0004
0084103603091912-0003
0084103603090212-0002
0084103603089612-0001
0084103602428403-1218
0084103602426003-1210
0084103602425303-1205
0084103602424603-1200
0084103602315702-9128
0084103602313302-9122
0084103602173302-5290
0084103600714001-0263
00841036135096SP-2298
0084103602360703-0073

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