Identity
- Trade Name
- CARDINAL HEALTH FDA UDI
- Generic Name
- Cardiothoracic surgical procedure kit, non-medicated, single-use FDA UDI
- Device Name
- STERILE CAROTID VASCULAR PACK FDA UDI
- Model / Reference
- SCV11CTRJO FDA UDI
- Description
- STERILE CAROTID VASCULAR PACK FDA UDI
Identifiers
- Catalog Number
- SCV11CTRJO FDA UDI
- Primary DI / UDI-DI
- 10887488543659 FDA UDI
- FDA Product Code
- OEZ FDA UDI
- GMDN Term
- Cardiothoracic surgical procedure kit, non-medicated, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1200 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Contains Latex
Yes
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: Cardiothoracic surgical procedure kit, non-medicated, single-use
Cardinal Health's Cardiovascular Procedure Kit is a sterile, single-use device designed for assisting cardiothoracic surgical procedures. This kit contains various instruments and materials, including dressings and materials, intended to be used during cardiothoracic surgery but not dedicated to a specific type of procedure.
Similar devices
Also classified as Cardiothoracic surgical procedure kit, non-medicated, single-use.
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class II
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class II
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class II
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class II
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class II
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class II
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class II
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class II
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 II | Pending data |
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Manufacturer
- Manufacturer
- Cardinal Health 200, LLC
Sources (1)
- FDA UDI 0cff625b-8c84-4595-a513-f0af5a210a76 35 fields · synced Jun 28, 2026