1.5MM SYSTEM - CRANIOCURVE (TM) MESH 01-9521

GUDID 00841036153656

BIOMET MICROFIXATION, INC

Cranioplasty plate, alterable
Primary Device ID00841036153656
NIH Device Record Key53312bb2-09f2-4ee8-968b-cfa9a64155e1
Commercial Distribution StatusIn Commercial Distribution
Brand Name1.5MM SYSTEM - CRANIOCURVE (TM) MESH
Version Model Number01-9521
Catalog Number01-9521
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100841036153656 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GXRCOVER, BURR HOLE

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00841036153656]

Moist Heat or Steam Sterilization


[00841036153656]

Moist Heat or Steam Sterilization


[00841036153656]

Moist Heat or Steam Sterilization


[00841036153656]

Moist Heat or Steam Sterilization


[00841036153656]

Moist Heat or Steam Sterilization


[00841036153656]

Moist Heat or Steam Sterilization


[00841036153656]

Moist Heat or Steam Sterilization


[00841036153656]

Moist Heat or Steam Sterilization


[00841036153656]

Moist Heat or Steam Sterilization


[00841036153656]

Moist Heat or Steam Sterilization


[00841036153656]

Moist Heat or Steam Sterilization


[00841036153656]

Moist Heat or Steam Sterilization


[00841036153656]

Moist Heat or Steam Sterilization


[00841036153656]

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 [1.5MM SYSTEM - CRANIOCURVE (TM) MESH]

00841036201289SP-3253
00841036193881SP-3235
00841036193874SP-3234
00841036193867SP-3233
00841036193850SP-3232
00841036193843SP-3231
0084103615565001-9523
0084103615564301-9524
0084103615366301-9522
0084103615365601-9521
0084103615364901-9520

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