EXTERNAL DISTRACTION SYSTEM 99-5924

GUDID 00841036072650

BIOMET MICROFIXATION, INC

Orthopaedic bone wire Orthopaedic bone wire
Primary Device ID00841036072650
NIH Device Record Keyd38331f7-ddef-4f45-8c6d-586f6f6fa475
Commercial Distribution StatusIn Commercial Distribution
Brand NameEXTERNAL DISTRACTION SYSTEM
Version Model Number99-5924
Catalog Number99-5924
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100841036072650 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HTYPIN, FIXATION, SMOOTH

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00841036072650]

Moist Heat or Steam Sterilization


[00841036072650]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-11-25

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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