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Vanguard® Complete Knee System

FDA UDI

Class II (US FDA UDI)

by Biomet Orthopedics, Inc.

Identity

Trade Name
Vanguard® Complete Knee System FDA UDI
Generic Name
Uncoated knee tibia/insert prosthesis FDA UDI
Model / Reference
195634 FDA UDI

Identifiers

Catalog Number
195634 FDA UDI
Primary DI / UDI-DI
00880304991163 FDA UDI
FDA Product Code
MBH FDA UDI
MBV FDA UDI
OIY FDA UDI
JWH FDA UDI
GMDN Term
Uncoated knee tibia/insert prosthesis FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3565 FDA UDI
888.3560 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: Uncoated knee tibia/insert prosthesis

Vanguard® Complete Knee System by Biomet Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Uncoated knee tibia/insert prosthesis.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Biomet Orthopedics, Inc.

Sources (1)

  • FDA UDI 6704f854-8824-46b5-88df-eb4df888c6c5 35 fields · synced May 30, 2026