VANGUARD 360 REVISION REAMERS 591204

GUDID 00880304532540

Biomet Orthopedics, LLC

Instrument tray
Primary Device ID00880304532540
NIH Device Record Key8e3bccdc-f2ea-4ed7-a87c-03bf7db297b2
Commercial Distribution StatusIn Commercial Distribution
Brand NameVANGUARD 360 REVISION REAMERS
Version Model Number591204
Catalog Number591204
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
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
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
GS100880304532540 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JWHPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00880304532540]

Moist Heat or Steam Sterilization


[00880304532540]

Moist Heat or Steam Sterilization


[00880304532540]

Moist Heat or Steam Sterilization


[00880304532540]

Moist Heat or Steam Sterilization


[00880304532540]

Moist Heat or Steam Sterilization


[00880304532540]

Moist Heat or Steam Sterilization


[00880304532540]

Moist Heat or Steam Sterilization


[00880304532540]

Moist Heat or Steam Sterilization


[00880304532540]

Moist Heat or Steam Sterilization


[00880304532540]

Moist Heat or Steam Sterilization


[00880304532540]

Moist Heat or Steam Sterilization


[00880304532540]

Moist Heat or Steam Sterilization


[00880304532540]

Moist Heat or Steam Sterilization


[00880304532540]

Moist Heat or Steam Sterilization


[00880304532540]

Moist Heat or Steam Sterilization


[00880304532540]

Moist Heat or Steam Sterilization


[00880304532540]

Moist Heat or Steam Sterilization


[00880304532540]

Moist Heat or Steam Sterilization


[00880304532540]

Moist Heat or Steam Sterilization


[00880304532540]

Moist Heat or Steam Sterilization


[00880304532540]

Moist Heat or Steam Sterilization


[00880304532540]

Moist Heat or Steam Sterilization


[00880304532540]

Moist Heat or Steam Sterilization


[00880304532540]

Moist Heat or Steam Sterilization


[00880304532540]

Moist Heat or Steam Sterilization


[00880304532540]

Moist Heat or Steam Sterilization


[00880304532540]

Moist Heat or Steam Sterilization


[00880304532540]

Moist Heat or Steam Sterilization


[00880304532540]

Moist Heat or Steam Sterilization


[00880304532540]

Moist Heat or Steam Sterilization


[00880304532540]

Moist Heat or Steam Sterilization


[00880304532540]

Moist Heat or Steam Sterilization


[00880304532540]

Moist Heat or Steam Sterilization


[00880304532540]

Moist Heat or Steam Sterilization


[00880304532540]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-08-09
Device Publish Date2017-07-28

Devices Manufactured by Biomet Orthopedics, LLC

00887868578250 - Comprehensive®2024-11-13
08428898885684 - BIPASS DISPOSABLE PUSHER2024-09-11
08428898885691 - BIPASS DISPOSABLE PUSHER2024-09-11
00880304338548 - AGC ANTERIOR FILE2024-09-11
00880304339224 - PARALLEL PULLER2024-09-11
00880304342187 - AGC MODULAR TIBIAL II2024-09-11
00880304365247 - BIO-MODULAR2024-09-11
00880304368637 - BOHN MODULAR FEMORAL STEM EXTRACTOR2024-09-11

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