1.5 SYSTEM SP-2321

GUDID 00888233016025

BIOMET MICROFIXATION, INC

Craniofacial fixation plate, non-bioabsorbable
Primary Device ID00888233016025
NIH Device Record Key43701213-49f1-465c-8304-f7559bd117fa
Commercial Distribution StatusIn Commercial Distribution
Brand Name1.5 SYSTEM
Version Model NumberSP-2321
Catalog NumberSP-2321
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100888233016025 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GXRCOVER, BURR HOLE

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00888233016025]

Moist Heat or Steam Sterilization


[00888233016025]

Moist Heat or Steam Sterilization


[00888233016025]

Moist Heat or Steam Sterilization


[00888233016025]

Moist Heat or Steam Sterilization


[00888233016025]

Moist Heat or Steam Sterilization


[00888233016025]

Moist Heat or Steam Sterilization


[00888233016025]

Moist Heat or Steam Sterilization


[00888233016025]

Moist Heat or Steam Sterilization


[00888233016025]

Moist Heat or Steam Sterilization


[00888233016025]

Moist Heat or Steam Sterilization


[00888233016025]

Moist Heat or Steam Sterilization


[00888233016025]

Moist Heat or Steam Sterilization


[00888233016025]

Moist Heat or Steam Sterilization


[00888233016025]

Moist Heat or Steam Sterilization


[00888233016025]

Moist Heat or Steam Sterilization


[00888233016025]

Moist Heat or Steam Sterilization


[00888233016025]

Moist Heat or Steam Sterilization


[00888233016025]

Moist Heat or Steam Sterilization


[00888233016025]

Moist Heat or Steam Sterilization


[00888233016025]

Moist Heat or Steam Sterilization


[00888233016025]

Moist Heat or Steam Sterilization


[00888233016025]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2021-02-05
Device Publish Date2020-06-16

On-Brand Devices [1.5 SYSTEM]

00841036282714SP-2088
00841036132873SP-2321
00841036132781SP-2332
00841036123420SP-2088
00888233016087SP-2332
00888233016025SP-2321

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