COMPRESS OSS FACE ADAPTOR TRIAL 110018816

GUDID 00880304679917

Biomet Orthopedics, LLC

Knee femur prosthesis trial
Primary Device ID00880304679917
NIH Device Record Key505fa9b9-4c37-4b45-af9c-1f9cfb365e77
Commercial Distribution StatusIn Commercial Distribution
Brand NameCOMPRESS OSS FACE ADAPTOR TRIAL
Version Model Number110018816
Catalog Number110018816
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100880304679917 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KROPROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00880304679917]

Moist Heat or Steam Sterilization


[00880304679917]

Moist Heat or Steam Sterilization


[00880304679917]

Moist Heat or Steam Sterilization


[00880304679917]

Moist Heat or Steam Sterilization


[00880304679917]

Moist Heat or Steam Sterilization


[00880304679917]

Moist Heat or Steam Sterilization


[00880304679917]

Moist Heat or Steam Sterilization


[00880304679917]

Moist Heat or Steam Sterilization


[00880304679917]

Moist Heat or Steam Sterilization


[00880304679917]

Moist Heat or Steam Sterilization


[00880304679917]

Moist Heat or Steam Sterilization


[00880304679917]

Moist Heat or Steam Sterilization


[00880304679917]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-02-07
Device Publish Date2018-12-19

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00887868578250 - Comprehensive®2024-11-13
08428898885684 - BIPASS DISPOSABLE PUSHER2024-09-11
08428898885691 - BIPASS DISPOSABLE PUSHER2024-09-11
00880304338548 - AGC ANTERIOR FILE2024-09-11

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