DFS DIMENSION DISTAL RADIUS FIXATOR 04330

GUDID 00888480107415

Biomet Orthopedics, LLC

External orthopaedic fixation system, single-use, non-sterile
Primary Device ID00888480107415
NIH Device Record Key6e541df0-6381-4772-acbb-b2917171f9a2
Commercial Distribution StatusIn Commercial Distribution
Brand NameDFS DIMENSION DISTAL RADIUS FIXATOR
Version Model Number04330
Catalog Number04330
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
GS100888480107415 [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

[00888480107415]

Moist Heat or Steam Sterilization


[00888480107415]

Moist Heat or Steam Sterilization


[00888480107415]

Moist Heat or Steam Sterilization


[00888480107415]

Moist Heat or Steam Sterilization


[00888480107415]

Moist Heat or Steam Sterilization


[00888480107415]

Moist Heat or Steam Sterilization


[00888480107415]

Moist Heat or Steam Sterilization


[00888480107415]

Moist Heat or Steam Sterilization


[00888480107415]

Moist Heat or Steam Sterilization


[00888480107415]

Moist Heat or Steam Sterilization


[00888480107415]

Moist Heat or Steam Sterilization


[00888480107415]

Moist Heat or Steam Sterilization


[00888480107415]

Moist Heat or Steam Sterilization


[00888480107415]

Moist Heat or Steam Sterilization


[00888480107415]

Moist Heat or Steam Sterilization


[00888480107415]

Moist Heat or Steam Sterilization


[00888480107415]

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 DIMENSION DISTAL RADIUS FIXATOR]

0088848010741504330
0088786808246704300

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