Vanguard® 32-489023

GUDID 00887868497629

Biomet Orthopedics, LLC

Knee tibia prosthesis trial

• Primary Device ID: 00887868497629
• NIH Device Record Key: 51bd48b5-00dc-40dd-9977-f0dc06d330c6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vanguard®
• Version Model Number: 32-489023
• Catalog Number: 32-489023
• Company DUNS: 129278169
• Company Name: Biomet Orthopedics, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com

Device Dimensions

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00887868497629 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113550

FDA Product Code

• JWH: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00887868497629]

Moist Heat or Steam Sterilization

[00887868497629]

Moist Heat or Steam Sterilization

[00887868497629]

Moist Heat or Steam Sterilization

[00887868497629]

Moist Heat or Steam Sterilization

[00887868497629]

Moist Heat or Steam Sterilization

[00887868497629]

Moist Heat or Steam Sterilization

[00887868497629]

Moist Heat or Steam Sterilization

[00887868497629]

Moist Heat or Steam Sterilization

[00887868497629]

Moist Heat or Steam Sterilization

[00887868497629]

Moist Heat or Steam Sterilization

[00887868497629]

Moist Heat or Steam Sterilization

[00887868497629]

Moist Heat or Steam Sterilization

[00887868497629]

Moist Heat or Steam Sterilization

[00887868497629]

Moist Heat or Steam Sterilization

[00887868497629]

Moist Heat or Steam Sterilization

[00887868497629]

Moist Heat or Steam Sterilization

[00887868497629]

Moist Heat or Steam Sterilization

[00887868497629]

Moist Heat or Steam Sterilization

[00887868497629]

Moist Heat or Steam Sterilization

[00887868497629]

Moist Heat or Steam Sterilization

[00887868497629]

Moist Heat or Steam Sterilization

[00887868497629]

Moist Heat or Steam Sterilization

[00887868497629]

Moist Heat or Steam Sterilization

[00887868497629]

Moist Heat or Steam Sterilization

[00887868497629]

Moist Heat or Steam Sterilization

[00887868497629]

Moist Heat or Steam Sterilization

[00887868497629]

Moist Heat or Steam Sterilization

[00887868497629]

Moist Heat or Steam Sterilization

[00887868497629]

Moist Heat or Steam Sterilization

[00887868497629]

Moist Heat or Steam Sterilization

[00887868497629]

Moist Heat or Steam Sterilization

[00887868497629]

Moist Heat or Steam Sterilization

[00887868497629]

Moist Heat or Steam Sterilization

[00887868497629]

Moist Heat or Steam Sterilization

[00887868497629]

Moist Heat or Steam Sterilization

[00887868497629]

Moist Heat or Steam Sterilization

[00887868497629]

Moist Heat or Steam Sterilization

[00887868497629]

Moist Heat or Steam Sterilization

[00887868497629]

Moist Heat or Steam Sterilization

[00887868497629]

Moist Heat or Steam Sterilization

[00887868497629]

Moist Heat or Steam Sterilization

[00887868497629]

Moist Heat or Steam Sterilization

[00887868497629]

Moist Heat or Steam Sterilization

[00887868497629]

Moist Heat or Steam Sterilization

[00887868497629]

Moist Heat or Steam Sterilization

[00887868497629]

Moist Heat or Steam Sterilization

[00887868497629]

Moist Heat or Steam Sterilization

[00887868497629]

Moist Heat or Steam Sterilization

[00887868497629]

Moist Heat or Steam Sterilization

[00887868497629]

Moist Heat or Steam Sterilization

[00887868497629]

Moist Heat or Steam Sterilization

[00887868497629]

Moist Heat or Steam Sterilization

[00887868497629]

Moist Heat or Steam Sterilization

[00887868497629]

Moist Heat or Steam Sterilization

[00887868497629]

Moist Heat or Steam Sterilization

[00887868497629]

Moist Heat or Steam Sterilization

[00887868497629]

Moist Heat or Steam Sterilization

[00887868497629]

Moist Heat or Steam Sterilization

[00887868497629]

Moist Heat or Steam Sterilization

[00887868497629]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-04-01
• Device Publish Date: 2021-03-24

On-Brand Devices [Vanguard®]

• 00887868498268: 32-489150
• 00887868498251: 32-489148
• 00887868498244: 32-489146
• 00887868498237: 32-489144
• 00887868498220: 32-489143
• 00887868498213: 32-489142
• 00887868498206: 32-489141
• 00887868498190: 32-489140
• 00887868498121: 32-489123
• 00887868498107: 32-489121
• 00887868498022: 32-489103
• 00887868498008: 32-489101
• 00887868497926: 32-489083
• 00887868497902: 32-489081
• 00887868497827: 32-489063
• 00887868497803: 32-489061
• 00887868497728: 32-489043
• 00887868497704: 32-489041
• 00887868497629: 32-489023
• 00887868497605: 32-489021
• 00887868497582: 32-489010
• 00887868497575: 32-489008
• 00887868497568: 32-489006
• 00887868497551: 32-489004
• 00887868497544: 32-489003
• 00887868497537: 32-489002
• 00887868497520: 32-489001
• 00887868497513: 32-489000
• 00887868496219: 32-487233
• 00887868496202: 32-487232
• 00887868496196: 32-487231
• 00887868496189: 32-487230
• 00887868495724: 32-487120
• 00887868495557: 32-487040
• 00887868490361: 32-483036
• 00887868490354: 32-483034
• 00887868490347: 32-483033
• 00887868490330: 32-483032
• 00887868490323: 32-483030
• 00887868490316: 32-483028
• 00887868490309: 32-483026
• 00887868490293: 32-483024
• 00887868490286: 32-483022
• 00887868490279: 32-483020
• 00887868490262: 32-483016
• 00887868490255: 32-483014
• 00887868490248: 32-483013
• 00887868490231: 32-483012
• 00887868490224: 32-483010
• 00887868490217: 32-483008