Identity
- Trade Name
- CARDINAL HEALTH FDA UDI
- Generic Name
- Obstetrical/gynaecological surgical procedure kit, non-medicated, single-use FDA UDI
- Device Name
- C SECTION PACK FDA UDI
- Model / Reference
- SMA29CSAH1 FDA UDI
- Description
- C SECTION PACK FDA UDI
Identifiers
- Catalog Number
- SMA29CSAH1 FDA UDI
- Primary DI / UDI-DI
- 10195594366964 FDA UDI
- FDA Product Code
- OHM FDA UDI
- GMDN Term
- Obstetrical/gynaecological surgical procedure kit, non-medicated, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.1720 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: Obstetrical/gynaecological surgical procedure kit, non-medicated, single-use
Cardinal Health's Cesarean Section Tray, or C-section tray, is a sterile surgical instrument kit specifically designed for obstetrical and gynecological procedures. This device is a key component of the Cesarean section process, providing a comprehensive set of instruments for surgeons to perform this critical procedure.
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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 6c60f4c7-4cf8-409a-913f-a4cd2a460683 34 fields · synced Oct 6, 2026