DYNAFIX VS OSTEOTOMY SYSTEM 14034P

GUDID 00887868090042

Biomet Orthopedics, LLC

Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile
Primary Device ID00887868090042
NIH Device Record Key13ffbe5a-6572-464c-980d-4d9ba800db7e
Commercial Distribution StatusIn Commercial Distribution
Brand NameDYNAFIX VS OSTEOTOMY SYSTEM
Version Model Number14034P
Catalog Number14034P
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

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100887868090042 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NDHNAIL, FIXATION, BONE, METALLIC

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00887868090042]

Moist Heat or Steam Sterilization


[00887868090042]

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

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0088030453214411050P
0088030452920510050P
0088030450677011062P
0088030450561210125P
0088030450485112175P
0088030449804410062P
0088030449506712150P
0088030449290513150P
0088030449190810112P
0088030449084011075P
0088030448748211100P
0088030448696610075P
0088030448669010088P
0088030448662111088P
0088030448608911125P
0088030448567910100P
0088030448560011112P
0088848018811714085P
0088848018779014026P
0088848018777614024P
0088848015351113225P
0088848015349813200P
0088848015345013175P
0088786815137814030P
0088786809019614090P
0088786809017214080P
0088786809016514075P
0088786809015814070P
0088786809014114065P
0088786809013414060P
0088786809012714055P
0088786809011014050P
0088786809010314045P
0088786809009714044P
0088786809008014042P
0088786809007314040P
0088786809006614038P
0088786809005914036P
0088786809004214034P
0088786809003514032P
0088786809001114028P
0088786808991612225P

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