COMPRESS DEVICE 178371

GUDID 00880304508996

Biomet Orthopedics, LLC

Body femoral/tibial extension stem, coated
Primary Device ID00880304508996
NIH Device Record Keyc42b47e9-274b-4e2d-a147-4a1c494a9032
Commercial Distribution StatusIn Commercial Distribution
Brand NameCOMPRESS DEVICE
Version Model Number178371
Catalog Number178371
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 Datetrue
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

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 Identifiers

Device Issuing AgencyDevice ID
GS100880304508996 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

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

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-05-22
Device Publish Date2015-10-24

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00880304554887178784
00880304554870178759
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00880304554856178756
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00880304509030178365
00880304509023178350
00880304509016178361
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00880304508996178371
00880304508989178359
00880304508972178358
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00880304508958178357
00880304508941178351
00880304508934178352
00880304508927178363
00880304508910178367
00880304508903178372
00880304505094178729
00880304502062178727
00880304500525178726
00880304500518178724

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