WRISTFIX 13122

GUDID 00888480153245

Biomet Orthopedics, LLC

External orthopaedic fixation system, single-use, non-sterile
Primary Device ID00888480153245
NIH Device Record Key41bd613a-485d-4086-b577-d08f21595f32
Commercial Distribution StatusIn Commercial Distribution
Brand NameWRISTFIX
Version Model Number13122
Catalog Number13122
Company DUNS129278169
Company NameBiomet Orthopedics, LLC
Device Count3
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(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com

Device Dimensions

Device Size Text, specify0
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Device Size Text, specify0
Device Size Text, specify0
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Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100888480153245 [Primary]
GS170888480153244 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KTTAPPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00888480153245]

Moist Heat or Steam Sterilization


[00888480153245]

Moist Heat or Steam Sterilization


[00888480153245]

Moist Heat or Steam Sterilization


[00888480153245]

Moist Heat or Steam Sterilization


[00888480153245]

Moist Heat or Steam Sterilization


[00888480153245]

Moist Heat or Steam Sterilization


[00888480153245]

Moist Heat or Steam Sterilization


[00888480153245]

Moist Heat or Steam Sterilization


[00888480153245]

Moist Heat or Steam Sterilization


[00888480153245]

Moist Heat or Steam Sterilization


[00888480153245]

Moist Heat or Steam Sterilization


[00888480153245]

Moist Heat or Steam Sterilization


[00888480153245]

Moist Heat or Steam Sterilization


[00888480153245]

Moist Heat or Steam Sterilization


[00888480153245]

Moist Heat or Steam Sterilization


[00888480153245]

Moist Heat or Steam Sterilization


[00888480153245]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-10-24

On-Brand Devices [WRISTFIX]

0088848015324513122
0088786808245004250
0088786808244304240
0088786808239904220
0088786808238204200

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