EXTERNAL DISTRACTION SYSTEM 99-3581

GUDID 00841036057428

BIOMET MICROFIXATION, INC

Implantable craniofacial bone distractor
Primary Device ID00841036057428
NIH Device Record Keya3d5ee3d-98eb-4611-bcf9-094ba7b35f8f
Commercial Distribution StatusIn Commercial Distribution
Brand NameEXTERNAL DISTRACTION SYSTEM
Version Model Number99-3581
Catalog Number99-3581
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
GS100841036057428 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MQNEXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00841036057428]

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 [EXTERNAL DISTRACTION SYSTEM]

0084103605743599-3582
0084103605742899-3581
0084103605741199-3575
0084103605740499-3572
0084103605739899-3570
0084103601094201-3587
0084103601093501-3586
0084103601092801-3585
0084103601091101-3584
0084103601090401-3580
0084103601085001-3552
0084103601084301-3551
0084103607265099-5924
0084103607088599-5918
0084103606679699-5926
0084103601133801-5926
0084103601132101-5924
0084103601131401-5918

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