2.0MM SYSTEM SP-3137

GUDID 00841036173241

BIOMET MICROFIXATION, INC

Craniofacial fixation plate, non-bioabsorbable
Primary Device ID00841036173241
NIH Device Record Key7cae6cf0-613e-495d-961d-f3dcc81986bd
Commercial Distribution StatusIn Commercial Distribution
Brand Name2.0MM SYSTEM
Version Model NumberSP-3137
Catalog NumberSP-3137
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
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
GS100841036173241 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JEYPLATE, BONE

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00841036173241]

Moist Heat or Steam Sterilization


[00841036173241]

Moist Heat or Steam Sterilization


[00841036173241]

Moist Heat or Steam Sterilization


[00841036173241]

Moist Heat or Steam Sterilization


[00841036173241]

Moist Heat or Steam Sterilization


[00841036173241]

Moist Heat or Steam Sterilization


[00841036173241]

Moist Heat or Steam Sterilization


[00841036173241]

Moist Heat or Steam Sterilization


[00841036173241]

Moist Heat or Steam Sterilization


[00841036173241]

Moist Heat or Steam Sterilization


[00841036173241]

Moist Heat or Steam Sterilization


[00841036173241]

Moist Heat or Steam Sterilization


[00841036173241]

Moist Heat or Steam Sterilization


[00841036173241]

Moist Heat or Steam Sterilization


[00841036173241]

Moist Heat or Steam Sterilization


[00841036173241]

Moist Heat or Steam Sterilization


[00841036173241]

Moist Heat or Steam Sterilization


[00841036173241]

Moist Heat or Steam Sterilization


[00841036173241]

Moist Heat or Steam Sterilization


[00841036173241]

Moist Heat or Steam Sterilization


[00841036173241]

Moist Heat or Steam Sterilization


[00841036173241]

Moist Heat or Steam Sterilization


[00841036173241]

Moist Heat or Steam Sterilization


[00841036173241]

Moist Heat or Steam Sterilization


[00841036173241]

Moist Heat or Steam Sterilization


[00841036173241]

Moist Heat or Steam Sterilization


[00841036173241]

Moist Heat or Steam Sterilization


[00841036173241]

Moist Heat or Steam Sterilization


[00841036173241]

Moist Heat or Steam Sterilization


[00841036173241]

Moist Heat or Steam Sterilization


[00841036173241]

Moist Heat or Steam Sterilization


[00841036173241]

Moist Heat or Steam Sterilization


[00841036173241]

Moist Heat or Steam Sterilization


[00841036173241]

Moist Heat or Steam Sterilization


[00841036173241]

Moist Heat or Steam Sterilization


[00841036173241]

Moist Heat or Steam Sterilization


[00841036173241]

Moist Heat or Steam Sterilization


[00841036173241]

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 [2.0MM SYSTEM]

00841036282721SP-2094
00841036282646SP-2003
00841036241766SP-3387
00841036227937SP-3307
0084103621957491-2005-50
0084103621956791-2007-50
0084103621955091-2009-50
0084103621948291-6205-50
0084103621947591-6207-50
00841036209384SP-3304
00841036209377SP-3303
00841036206925SP-3299
00841036203870SP-3259
00841036199814SP-1992
00841036199678SP-1782
00841036199586SP-1184
00841036199579SP-1183
00841036178963SP-3145
00841036174019SP-3072
00841036174002SP-3071
00841036173258SP-3138
00841036173241SP-3137
00841036173234SP-3136
00841036173227SP-3135
00841036173067SP-3084
00841036173050SP-3083
00841036173043SP-3082
00841036173036SP-3081
00841036173029SP-3080
00841036173012SP-3079
00841036173005SP-3078
00841036172992SP-3077
00841036172985SP-3076
00841036172978SP-3075
00841036172961SP-3074
00841036172954SP-3073
00841036172169SP-3131-R
00841036172152SP-3130-R
00841036172145SP-3129-R
00841036172138SP-3128-R
00841036172121SP-3127-R
00841036172114SP-3126-R
00841036172107SP-3125-R
00841036172091SP-3124-R
00841036172084SP-3123-R
00841036172077SP-3122-R
00841036172060SP-3120-R
00841036172053SP-3131-L
00841036172046SP-3130-L
00841036172039SP-3129-L

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