DFS HYBRID RING FIXATOR SYSTEM 13145

GUDID 00888480153320

Biomet Orthopedics, LLC

External orthopaedic fixation system, single-use, non-sterile
Primary Device ID00888480153320
NIH Device Record Keyb2ceaf0a-7de4-4561-8bc8-63912fbcdb52
Commercial Distribution StatusIn Commercial Distribution
Brand NameDFS HYBRID RING FIXATOR SYSTEM
Version Model Number13145
Catalog Number13145
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 Dimensions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100888480153320 [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

[00888480153320]

Moist Heat or Steam Sterilization


[00888480153320]

Moist Heat or Steam Sterilization


[00888480153320]

Moist Heat or Steam Sterilization


[00888480153320]

Moist Heat or Steam Sterilization


[00888480153320]

Moist Heat or Steam Sterilization


[00888480153320]

Moist Heat or Steam Sterilization


[00888480153320]

Moist Heat or Steam Sterilization


[00888480153320]

Moist Heat or Steam Sterilization


[00888480153320]

Moist Heat or Steam Sterilization


[00888480153320]

Moist Heat or Steam Sterilization


[00888480153320]

Moist Heat or Steam Sterilization


[00888480153320]

Moist Heat or Steam Sterilization


[00888480153320]

Moist Heat or Steam Sterilization


[00888480153320]

Moist Heat or Steam Sterilization


[00888480153320]

Moist Heat or Steam Sterilization


[00888480153320]

Moist Heat or Steam Sterilization


[00888480153320]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-26

On-Brand Devices [DFS HYBRID RING FIXATOR SYSTEM]

0088030453176513060
0088030449304913055
0088030449180913070
0088030449177913160
0088030449166313065
0088848015332013145
0088848015331313140
0088848015314613085
0088848015304713030
0088848015301613015
0088786808998513210

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