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Instrument

FDA UDI

Class II (US FDA UDI)

by Howmedica Osteonics Corp.

Identity

Trade Name
INSTRUMENT FDA UDI
Generic Name
Orthopaedic surgical procedure kit, non-medicated, single-use FDA UDI
Device Name
TRIATHLON SINGLE-USE TIBIAL PREP KIT FDA UDI
Model / Reference
5555-2322 FDA UDI
Description
TRIATHLON SINGLE-USE TIBIAL PREP KIT FDA UDI

Identifiers

Catalog Number
5555-2322 FDA UDI
Primary DI / UDI-DI
07613327256185 FDA UDI
FDA Product Code
JWH FDA UDI
MBH FDA UDI
KRR FDA UDI
HRY FDA UDI
NPJ FDA UDI
HSX FDA UDI
GMDN Term
Orthopaedic surgical procedure kit, non-medicated, single-use FDA UDI

Classification

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

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

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

Category: Orthopaedic surgical procedure kit, non-medicated, single-use

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

Similar devices

Also classified as Orthopaedic surgical procedure kit, non-medicated, single-use.

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 7c06dff1-e759-4115-947b-19b0ba20380b 35 fields · synced Jun 8, 2026