Identity
- Trade Name
- CARDINAL HEALTH FDA UDI
- Generic Name
- Arthroscopic surgical procedure kit, non-medicated, single-use FDA UDI
- Device Name
- KNEE ARTHROSCOPY PACK FDA UDI
- Model / Reference
- SOPCGKANO8 FDA UDI
- Description
- KNEE ARTHROSCOPY PACK FDA UDI
Identifiers
- Catalog Number
- SOPCGKANO8 FDA UDI
- Primary DI / UDI-DI
- 10197106278697 FDA UDI
- FDA Product Code
- OJH FDA UDI
- GMDN Term
- Arthroscopic 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
Single Use
Yes
Implantable
No
Contains Latex
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
Yes
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Arthroscopic surgical procedure kit, non-medicated, single-use
Cardinal Health's KNEE ARTHROSCOPY PACK is a comprehensive arthroscopic surgical procedure kit designed for orthopedic surgeons, specifically for knee arthroscopy procedures. This single-use device features sterilization prior to use and includes all necessary instruments and materials to ensure precise and safe outcomes.
Similar devices
Also classified as Arthroscopic surgical procedure kit, non-medicated, single-use.
- ENDOBUTTON — Smith & Nephew, Inc. · Class I
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class I
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class I
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class I
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class I
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class I
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class I
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Cardinal Health 200, LLC
Sources (1)
- FDA UDI dd694ab2-349d-4b34-a57e-2a89b24baa48 35 fields · synced Oct 7, 2026