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Cardinal Health

FDA UDI

Class I (US FDA UDI)

by Cardinal Health 200, LLC

Identity

Trade Name
CARDINAL HEALTH FDA UDI
Generic Name
Orthopaedic surgical procedure kit, non-medicated, single-use FDA UDI
Device Name
KIT, TOTAL JOINT FDA UDI
Model / Reference
PO44TJWB7 FDA UDI
Description
KIT, TOTAL JOINT FDA UDI

Identifiers

Catalog Number
PO44TJWB7 FDA UDI
Primary DI / UDI-DI
10197106041949 FDA UDI
FDA Product Code
OJH FDA UDI
GMDN Term
Orthopaedic surgical procedure kit, non-medicated, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4800 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

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

Cardinal Health's Orthopaedic Surgical Procedure Kit (Orthopedic Tray) is a sterile, single-use device designed for general orthopaedic surgical procedures. This kit contains various sterile instruments and materials, such as dressings and other materials intended to be used in non-medicated, single-use applications.

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
Cardinal Health 200, LLC

Sources (1)

  • FDA UDI 4b68a90d-5230-4ca9-9cdf-a2eb5d66c0ed 35 fields · synced Oct 6, 2026