TRAUMAONE SYSTEM SP-3009

GUDID 00841036164539

BIOMET MICROFIXATION, INC

Craniofacial fixation plate, non-bioabsorbable
Primary Device ID00841036164539
NIH Device Record Key571974ac-d9ff-476e-9c3e-5a22bd6df068
Commercial Distribution StatusIn Commercial Distribution
Brand NameTRAUMAONE SYSTEM
Version Model NumberSP-3009
Catalog NumberSP-3009
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 Usetrue
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
Phone+1(904)741-4400
EmailFXJAX-ORDERS@ZIMMERBIOMET.COM
Phone+1(904)741-4400
EmailFXJAX-ORDERS@ZIMMERBIOMET.COM
Phone+1(904)741-4400
EmailFXJAX-ORDERS@ZIMMERBIOMET.COM
Phone+1(904)741-4400
EmailFXJAX-ORDERS@ZIMMERBIOMET.COM
Phone+1(904)741-4400
EmailFXJAX-ORDERS@ZIMMERBIOMET.COM
Phone+1(904)741-4400
EmailFXJAX-ORDERS@ZIMMERBIOMET.COM
Phone+1(904)741-4400
EmailFXJAX-ORDERS@ZIMMERBIOMET.COM
Phone+1(904)741-4400
EmailFXJAX-ORDERS@ZIMMERBIOMET.COM
Phone+1(904)741-4400
EmailFXJAX-ORDERS@ZIMMERBIOMET.COM
Phone+1(904)741-4400
EmailFXJAX-ORDERS@ZIMMERBIOMET.COM
Phone+1(904)741-4400
EmailFXJAX-ORDERS@ZIMMERBIOMET.COM
Phone+1(904)741-4400
EmailFXJAX-ORDERS@ZIMMERBIOMET.COM
Phone+1(904)741-4400
EmailFXJAX-ORDERS@ZIMMERBIOMET.COM
Phone+1(904)741-4400
EmailFXJAX-ORDERS@ZIMMERBIOMET.COM
Phone+1(904)741-4400
EmailFXJAX-ORDERS@ZIMMERBIOMET.COM
Phone+1(904)741-4400
EmailFXJAX-ORDERS@ZIMMERBIOMET.COM
Phone+1(904)741-4400
EmailFXJAX-ORDERS@ZIMMERBIOMET.COM
Phone+1(904)741-4400
EmailFXJAX-ORDERS@ZIMMERBIOMET.COM
Phone+1(904)741-4400
EmailFXJAX-ORDERS@ZIMMERBIOMET.COM
Phone+1(904)741-4400
EmailFXJAX-ORDERS@ZIMMERBIOMET.COM
Phone+1(904)741-4400
EmailFXJAX-ORDERS@ZIMMERBIOMET.COM
Phone+1(904)741-4400
EmailFXJAX-ORDERS@ZIMMERBIOMET.COM
Phone+1(904)741-4400
EmailFXJAX-ORDERS@ZIMMERBIOMET.COM
Phone+1(904)741-4400
EmailFXJAX-ORDERS@ZIMMERBIOMET.COM
Phone+1(904)741-4400
EmailFXJAX-ORDERS@ZIMMERBIOMET.COM
Phone+1(904)741-4400
EmailFXJAX-ORDERS@ZIMMERBIOMET.COM
Phone+1(904)741-4400
EmailFXJAX-ORDERS@ZIMMERBIOMET.COM
Phone+1(904)741-4400
EmailFXJAX-ORDERS@ZIMMERBIOMET.COM
Phone+1(904)741-4400
EmailFXJAX-ORDERS@ZIMMERBIOMET.COM
Phone+1(904)741-4400
EmailFXJAX-ORDERS@ZIMMERBIOMET.COM
Phone+1(904)741-4400
EmailFXJAX-ORDERS@ZIMMERBIOMET.COM
Phone+1(904)741-4400
EmailFXJAX-ORDERS@ZIMMERBIOMET.COM
Phone+1(904)741-4400
EmailFXJAX-ORDERS@ZIMMERBIOMET.COM
Phone+1(904)741-4400
EmailFXJAX-ORDERS@ZIMMERBIOMET.COM
Phone+1(904)741-4400
EmailFXJAX-ORDERS@ZIMMERBIOMET.COM
Phone+1(904)741-4400
EmailFXJAX-ORDERS@ZIMMERBIOMET.COM
Phone+1(904)741-4400
EmailFXJAX-ORDERS@ZIMMERBIOMET.COM
Phone+1(904)741-4400
EmailFXJAX-ORDERS@ZIMMERBIOMET.COM

Device Identifiers

Device Issuing AgencyDevice ID
GS100841036164539 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JEYPLATE, BONE

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00841036164539]

Moist Heat or Steam Sterilization


[00841036164539]

Moist Heat or Steam Sterilization


[00841036164539]

Moist Heat or Steam Sterilization


[00841036164539]

Moist Heat or Steam Sterilization


[00841036164539]

Moist Heat or Steam Sterilization


[00841036164539]

Moist Heat or Steam Sterilization


[00841036164539]

Moist Heat or Steam Sterilization


[00841036164539]

Moist Heat or Steam Sterilization


[00841036164539]

Moist Heat or Steam Sterilization


[00841036164539]

Moist Heat or Steam Sterilization


[00841036164539]

Moist Heat or Steam Sterilization


[00841036164539]

Moist Heat or Steam Sterilization


[00841036164539]

Moist Heat or Steam Sterilization


[00841036164539]

Moist Heat or Steam Sterilization


[00841036164539]

Moist Heat or Steam Sterilization


[00841036164539]

Moist Heat or Steam Sterilization


[00841036164539]

Moist Heat or Steam Sterilization


[00841036164539]

Moist Heat or Steam Sterilization


[00841036164539]

Moist Heat or Steam Sterilization


[00841036164539]

Moist Heat or Steam Sterilization


[00841036164539]

Moist Heat or Steam Sterilization


[00841036164539]

Moist Heat or Steam Sterilization


[00841036164539]

Moist Heat or Steam Sterilization


[00841036164539]

Moist Heat or Steam Sterilization


[00841036164539]

Moist Heat or Steam Sterilization


[00841036164539]

Moist Heat or Steam Sterilization


[00841036164539]

Moist Heat or Steam Sterilization


[00841036164539]

Moist Heat or Steam Sterilization


[00841036164539]

Moist Heat or Steam Sterilization


[00841036164539]

Moist Heat or Steam Sterilization


[00841036164539]

Moist Heat or Steam Sterilization


[00841036164539]

Moist Heat or Steam Sterilization


[00841036164539]

Moist Heat or Steam Sterilization


[00841036164539]

Moist Heat or Steam Sterilization


[00841036164539]

Moist Heat or Steam Sterilization


[00841036164539]

Moist Heat or Steam Sterilization


[00841036164539]

Moist Heat or Steam Sterilization


[00841036164539]

Moist Heat or Steam Sterilization


[00841036164539]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-10-11

On-Brand Devices [TRAUMAONE SYSTEM]

00841036275389SP-2244
0084103627524201-0292
00841036282783SP-2194
0084103628169446-1505
0084103612856246-0006
0084103612854846-0015
00841036240806SP-3386
00841036217600SP-3310
00841036209483SP-3301
00841036206918SP-3295
00841036206901SP-3294
00841036203887SP-3260
0084103619762946-2463
00841036196042SP-3248
00841036195618SP-3247
00841036194413SP-3238
00841036194406SP-3237
00841036194390SP-3236
00841036194253SP-3228
00841036192914SP-3222
00841036188542SP-3207
00841036188535SP-3206
00841036188528SP-3205
00841036188511SP-3204
00841036188504SP-3203
00841036188498SP-3202
00841036188481SP-3201
00841036188474SP-3200
00841036187910SP-3221
00841036185459SP-3208-R
00841036185442SP-3209-R
00841036185435SP-3210-R
00841036185428SP-3210-L
00841036185411SP-3211-L
00841036185404SP-3211-R
00841036185398SP-3209-L
00841036185374SP-3208-L
0084103618435346-2462
00841036184179SP-3196
0084103618246501-0292
0084103618112301-0298
0084103618106291-5711
0084103618105591-5709
0084103618104891-5707
00841036177645SP-3070
00841036171704SP-3054
00841036170837SP-3053
00841036170752SP-3058
00841036170745SP-3057
00841036170288SP-3059

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