COMPRESS SEGMENTAL 32-481093

GUDID 00880304539228

Biomet Orthopedics, LLC

Knee femur prosthesis trial
Primary Device ID00880304539228
NIH Device Record Keyaf7b0596-49aa-43a6-bb51-620010e1edf8
Commercial Distribution StatusIn Commercial Distribution
Brand NameCOMPRESS SEGMENTAL
Version Model Number32-481093
Catalog Number32-481093
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
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 Identifiers

Device Issuing AgencyDevice ID
GS100880304539228 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JDIProsthesis, hip, semi-constrained, metal/polymer, cemented

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00880304539228]

Moist Heat or Steam Sterilization


[00880304539228]

Moist Heat or Steam Sterilization


[00880304539228]

Moist Heat or Steam Sterilization


[00880304539228]

Moist Heat or Steam Sterilization


[00880304539228]

Moist Heat or Steam Sterilization


[00880304539228]

Moist Heat or Steam Sterilization


[00880304539228]

Moist Heat or Steam Sterilization


[00880304539228]

Moist Heat or Steam Sterilization


[00880304539228]

Moist Heat or Steam Sterilization


[00880304539228]

Moist Heat or Steam Sterilization


[00880304539228]

Moist Heat or Steam Sterilization


[00880304539228]

Moist Heat or Steam Sterilization


[00880304539228]

Moist Heat or Steam Sterilization


[00880304539228]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-02-07
Device Publish Date2016-10-21

On-Brand Devices [COMPRESS SEGMENTAL]

0088030454122132-481095
0088030454121432-481098
0088030454120732-481097
0088030454119132-481096
0088030453922832-481093
0088030453921132-481094

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