DFS MINI EXTERNAL FIXATION SYSTEM M16-07015

GUDID 00887868104459

Biomet Orthopedics, LLC

External orthopaedic fixation system, single-use, non-sterile
Primary Device ID00887868104459
NIH Device Record Keyd0df5fb1-4c5f-4f56-8970-8cb5ef63f2a8
Commercial Distribution StatusIn Commercial Distribution
Brand NameDFS MINI EXTERNAL FIXATION SYSTEM
Version Model NumberM16-07015
Catalog NumberM16-07015
Company DUNS129278169
Company NameBiomet Orthopedics, LLC
Device Count4
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

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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
GS100887868104459 [Primary]
GS170887868104458 [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

[00887868104459]

Moist Heat or Steam Sterilization


[00887868104459]

Moist Heat or Steam Sterilization


[00887868104459]

Moist Heat or Steam Sterilization


[00887868104459]

Moist Heat or Steam Sterilization


[00887868104459]

Moist Heat or Steam Sterilization


[00887868104459]

Moist Heat or Steam Sterilization


[00887868104459]

Moist Heat or Steam Sterilization


[00887868104459]

Moist Heat or Steam Sterilization


[00887868104459]

Moist Heat or Steam Sterilization


[00887868104459]

Moist Heat or Steam Sterilization


[00887868104459]

Moist Heat or Steam Sterilization


[00887868104459]

Moist Heat or Steam Sterilization


[00887868104459]

Moist Heat or Steam Sterilization


[00887868104459]

Moist Heat or Steam Sterilization


[00887868104459]

Moist Heat or Steam Sterilization


[00887868104459]

Moist Heat or Steam Sterilization


[00887868104459]

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 MINI EXTERNAL FIXATION SYSTEM]

00887868104565M30-07030T
00887868104541M30-07025T
00887868104534M30-07020T
00887868104527M30-06025T
00887868104510M30-06020T
00887868104503M30-05018T
00887868104497M25-04520T
00887868104480M25-04015T
00887868104466M30-06030T
00887868104459M16-07015

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