DISTRACTION SYSTEM 01-3328

GUDID 00841036010676

BIOMET MICROFIXATION, INC

Implantable craniofacial bone distractor
Primary Device ID00841036010676
NIH Device Record Key7688b6f8-5696-4117-9fe7-e55acf9a4926
Commercial Distribution StatusIn Commercial Distribution
Brand NameDISTRACTION SYSTEM
Version Model Number01-3328
Catalog Number01-3328
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100841036010676 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MQNEXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00841036010676]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-09-23
Device Publish Date2015-10-11

On-Brand Devices [DISTRACTION SYSTEM]

0084103615131701-3338
0084103614623801-3487QC
00841036136031SP-2404
0084103609097501-3232
00841036090654915-3152
00841036090647915-3158
00841036089535915-3151
00841036089283915-3161
0084103608618301-3485QC
0084103608615201-3486QC
0084103608477601-3464QC
0084103607990115-3120
0084103607242101-3116QC
00841036072025915-3157
0084103607136301-3101QC
00841036071110915-3111
00841036071103915-3113
00841036071097915-3112
0084103606988901-3104QC
0084103606984101-3102QC
0084103606839401-3103QC
00841036067687915-3114
0084103606665901-3112QC
0084103606445701-3126QC
00841036061081915-3160
0084103601069001-3334
0084103601068301-3330
0084103601067601-3328
0084103601066901-3324
0084103601065201-3320
0084103609512301-3505
0084103609511601-3502
00841036092832SP-1580
00841036078225914-3330
00841036078218914-3110
00841036078195914-3320
0084103607521701-3542
0084103607514901-3500
0084103606511901-3205QC
00841036053857914-3137
0084103604671250-4080
0084103601218201-6880
0084103601089801-3563
0084103601088101-3558
0084103601087401-3557
0084103601086701-3556
0084103601053901-3234
0084103601052201-3229
0084103601049201-3204
0084103601048501-3202

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