THINFLAP SYSTEM 19-1055

GUDID 00841036088460

BIOMET MICROFIXATION, INC

Craniofacial fixation plate, non-bioabsorbable
Primary Device ID00841036088460
NIH Device Record Key34645736-39ee-4aa4-b117-8593d5423942
Commercial Distribution StatusIn Commercial Distribution
Brand NameTHINFLAP SYSTEM
Version Model Number19-1055
Catalog Number19-1055
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
GS100841036088460 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HBWFASTENER, PLATE, CRANIOPLASTY

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00841036088460]

Moist Heat or Steam Sterilization


[00841036088460]

Moist Heat or Steam Sterilization


[00841036088460]

Moist Heat or Steam Sterilization


[00841036088460]

Moist Heat or Steam Sterilization


[00841036088460]

Moist Heat or Steam Sterilization


[00841036088460]

Moist Heat or Steam Sterilization


[00841036088460]

Moist Heat or Steam Sterilization


[00841036088460]

Moist Heat or Steam Sterilization


[00841036088460]

Moist Heat or Steam Sterilization


[00841036088460]

Moist Heat or Steam Sterilization


[00841036088460]

Moist Heat or Steam Sterilization


[00841036088460]

Moist Heat or Steam Sterilization


[00841036088460]

Moist Heat or Steam Sterilization


[00841036088460]

Moist Heat or Steam Sterilization


[00841036088460]

Moist Heat or Steam Sterilization


[00841036088460]

Moist Heat or Steam Sterilization


[00841036088460]

Moist Heat or Steam Sterilization


[00841036088460]

Moist Heat or Steam Sterilization


[00841036088460]

Moist Heat or Steam Sterilization


[00841036088460]

Moist Heat or Steam Sterilization


[00841036088460]

Moist Heat or Steam Sterilization


[00841036088460]

Moist Heat or Steam Sterilization


[00841036088460]

Moist Heat or Steam Sterilization


[00841036088460]

Moist Heat or Steam Sterilization


[00841036088460]

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 [THINFLAP SYSTEM]

0084103621946891-6703-50
0084103621945191-6704-50
00841036191153SP-3218
00841036169312SP-3038
0084103615138691-6903
0084103615136295-6903
0084103614197491-6703
0084103614196795-6703
0084103613493891-6904
0084103613492195-6904
0084103613481595-6704
0084103613480891-6704
0084103612932319-1021
0084103612389591-6804-EA
0084103612293519-1019
0084103612290419-1020B
0084103612289891-6604-EA
0084103608850719-1075
0084103608849119-1070
0084103608848419-1065
0084103608847719-1060
0084103608846019-1055
0084103608845319-1050
0084103608844619-1045
0084103608843919-1040
0084103608842219-1035
00888233021555SP-3038
00888233018135SP-3218
0088823300722119-1021
0088823300023919-1020B
0088823300022219-1019
0088823302532491-6804-EA
0088823301230095-6903
0088823300164995-6904
0088823300163295-6704
0088823300162595-6703
0088823300157191-6904
0088823300156491-6903
0088823300155791-6704
0088823300154091-6703
0088823300153391-6604-EA

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