DISTAL RADIUS COMPLETE SYSTEM 04010

GUDID 00887868082238

Biomet Orthopedics, LLC

External orthopaedic fixation system, single-use, non-sterile
Primary Device ID00887868082238
NIH Device Record Keyd74c38fd-6f61-4120-b537-b7540e81632c
Commercial Distribution StatusIn Commercial Distribution
Brand NameDISTAL RADIUS COMPLETE SYSTEM
Version Model Number04010
Catalog Number04010
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
GS100887868082238 [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

[00887868082238]

Moist Heat or Steam Sterilization


[00887868082238]

Moist Heat or Steam Sterilization


[00887868082238]

Moist Heat or Steam Sterilization


[00887868082238]

Moist Heat or Steam Sterilization


[00887868082238]

Moist Heat or Steam Sterilization


[00887868082238]

Moist Heat or Steam Sterilization


[00887868082238]

Moist Heat or Steam Sterilization


[00887868082238]

Moist Heat or Steam Sterilization


[00887868082238]

Moist Heat or Steam Sterilization


[00887868082238]

Moist Heat or Steam Sterilization


[00887868082238]

Moist Heat or Steam Sterilization


[00887868082238]

Moist Heat or Steam Sterilization


[00887868082238]

Moist Heat or Steam Sterilization


[00887868082238]

Moist Heat or Steam Sterilization


[00887868082238]

Moist Heat or Steam Sterilization


[00887868082238]

Moist Heat or Steam Sterilization


[00887868082238]

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 [DISTAL RADIUS COMPLETE SYSTEM]

0088848010663004065
0088848010653104030
0088786808234404102
0088786808232004100
0088786808231304070
0088786808228304055
0088786808227604050
0088786808226904040
0088786808224504020
0088786808223804010

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