DFS DISTAL RADIUS FIXATOR 04310

GUDID 00888480107392

Biomet Orthopedics, LLC

External orthopaedic fixation system, single-use, non-sterile
Primary Device ID00888480107392
NIH Device Record Key7c34dfc0-4ad3-484f-869d-186431f1465a
Commercial Distribution StatusIn Commercial Distribution
Brand NameDFS DISTAL RADIUS FIXATOR
Version Model Number04310
Catalog Number04310
Company DUNS129278169
Company NameBiomet Orthopedics, LLC
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(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 Identifiers

Device Issuing AgencyDevice ID
GS100888480107392 [Primary]

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

[00888480107392]

Moist Heat or Steam Sterilization


[00888480107392]

Moist Heat or Steam Sterilization


[00888480107392]

Moist Heat or Steam Sterilization


[00888480107392]

Moist Heat or Steam Sterilization


[00888480107392]

Moist Heat or Steam Sterilization


[00888480107392]

Moist Heat or Steam Sterilization


[00888480107392]

Moist Heat or Steam Sterilization


[00888480107392]

Moist Heat or Steam Sterilization


[00888480107392]

Moist Heat or Steam Sterilization


[00888480107392]

Moist Heat or Steam Sterilization


[00888480107392]

Moist Heat or Steam Sterilization


[00888480107392]

Moist Heat or Steam Sterilization


[00888480107392]

Moist Heat or Steam Sterilization


[00888480107392]

Moist Heat or Steam Sterilization


[00888480107392]

Moist Heat or Steam Sterilization


[00888480107392]

Moist Heat or Steam Sterilization


[00888480107392]

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 [DFS DISTAL RADIUS FIXATOR]

0088848010739204310
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0088786808237504170
0088786808235104103
0088786808233704101
0088786808229004056
0088786808221404000

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