THINFLAP SP-1941

GUDID 00841036282639

BIOMET MICROFIXATION, INC

Craniofacial fixation plate, non-bioabsorbable
Primary Device ID00841036282639
NIH Device Record Key44b13c38-0b96-48cd-b50a-fe942da4d346
Commercial Distribution StatusIn Commercial Distribution
Brand NameTHINFLAP
Version Model NumberSP-1941
Catalog NumberSP-1941
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
Phone+1(904)741-4400
EmailFXJAX-ORDERS@ZIMMERBIOMET.COM

Device Identifiers

Device Issuing AgencyDevice ID
GS100841036282639 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GWOPlate, cranioplasty, preformed, alterable

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00841036282639]

Moist Heat or Steam Sterilization


[00841036282639]

Moist Heat or Steam Sterilization


[00841036282639]

Moist Heat or Steam Sterilization


[00841036282639]

Moist Heat or Steam Sterilization


[00841036282639]

Moist Heat or Steam Sterilization


[00841036282639]

Moist Heat or Steam Sterilization


[00841036282639]

Moist Heat or Steam Sterilization


[00841036282639]

Moist Heat or Steam Sterilization


[00841036282639]

Moist Heat or Steam Sterilization


[00841036282639]

Moist Heat or Steam Sterilization


[00841036282639]

Moist Heat or Steam Sterilization


[00841036282639]

Moist Heat or Steam Sterilization


[00841036282639]

Moist Heat or Steam Sterilization


[00841036282639]

Moist Heat or Steam Sterilization


[00841036282639]

Moist Heat or Steam Sterilization


[00841036282639]

Moist Heat or Steam Sterilization


[00841036282639]

Moist Heat or Steam Sterilization


[00841036282639]

Moist Heat or Steam Sterilization


[00841036282639]

Moist Heat or Steam Sterilization


[00841036282639]

Moist Heat or Steam Sterilization


[00841036282639]

Moist Heat or Steam Sterilization


[00841036282639]

Moist Heat or Steam Sterilization


[00841036282639]

Moist Heat or Steam Sterilization


[00841036282639]

Moist Heat or Steam Sterilization


[00841036282639]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-04-06
Device Publish Date2020-03-27

On-Brand Devices [THINFLAP]

00841036282639SP-1941
00841036199616SP-1680
00841036133405SP-2046
00841036131067SP-1943
00841036130428SP-1941
00841036130374SP-1942
0084103607985719-1030
0084103607984019-1010
0084103607983319-1005
0084103607982619-1020
0084103607962819-1015
0084103607960419-1025
00888233014267SP-2046
00888233014076SP-1943
00888233014069SP-1942

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.