Vanguard® Revision 32-488264

GUDID 00887868496981

Biomet Orthopedics, LLC

Knee tibia prosthesis trial, reusable

• Primary Device ID: 00887868496981
• NIH Device Record Key: ffa6b21e-e778-4e9b-b827-c528caee66c6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vanguard® Revision
• Version Model Number: 32-488264
• Catalog Number: 32-488264
• 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

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00887868496981 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142933

FDA Product Code

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

Sterilization

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

[00887868496981]

Moist Heat or Steam Sterilization

[00887868496981]

Moist Heat or Steam Sterilization

[00887868496981]

Moist Heat or Steam Sterilization

[00887868496981]

Moist Heat or Steam Sterilization

[00887868496981]

Moist Heat or Steam Sterilization

[00887868496981]

Moist Heat or Steam Sterilization

[00887868496981]

Moist Heat or Steam Sterilization

[00887868496981]

Moist Heat or Steam Sterilization

[00887868496981]

Moist Heat or Steam Sterilization

[00887868496981]

Moist Heat or Steam Sterilization

[00887868496981]

Moist Heat or Steam Sterilization

[00887868496981]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-05-16
• Device Publish Date: 2022-05-08

On-Brand Devices [Vanguard® Revision]

• 00887868509858: 595340
• 00887868509841: 595339
• 00887868509834: 595336
• 00887868509827: 595335
• 00887868509810: 595321
• 00887868497148: 32-488511
• 00887868497025: 32-488268
• 00887868497018: 32-488267
• 00887868497001: 32-488266
• 00887868496998: 32-488265
• 00887868496981: 32-488264
• 00887868496974: 32-488263
• 00887868496967: 32-488262
• 00887868496950: 32-488261
• 00887868496943: 32-488260
• 00887868496776: 32-488150
• 00887868496905: 32-488217
• 00887868496899: 32-488216
• 00887868496882: 32-488215