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Instrument

FDA UDI

Class II (US FDA UDI)

by Howmedica Osteonics Corp.

Identity

Trade Name
INSTRUMENT FDA UDI
Generic Name
Knee tibia prosthesis trial, reusable FDA UDI
Device Name
TS+ TIBIAL INSERT TRIAL - TRIATHLON REVISION INSTRUMENTS FDA UDI
Model / Reference
5537-T-428 FDA UDI
Description
TS+ TIBIAL INSERT TRIAL - TRIATHLON REVISION INSTRUMENTS FDA UDI

Identifiers

Catalog Number
5537-T-428 FDA UDI
Primary DI / UDI-DI
07613327247923 FDA UDI
FDA Product Code
KRR FDA UDI
NPJ FDA UDI
HRY FDA UDI
HSX FDA UDI
MBH FDA UDI
JWH FDA UDI
GMDN Term
Knee tibia prosthesis trial, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3540 FDA UDI
888.3560 FDA UDI
888.3530 FDA UDI
888.3520 FDA UDI
888.3565 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

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

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Knee tibia prosthesis trial, reusable

Instrument by Howmedica Osteonics Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Knee tibia prosthesis trial, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Howmedica Osteonics Corp.

Sources (1)

  • FDA UDI ae69af59-42b7-4ca2-905a-04d0eb5b5590 35 fields · synced May 30, 2026