Identity
- Trade Name
- CARDINAL HEALTH FDA UDI
- Generic Name
- Urological surgical procedure kit, non-medicated, single-use FDA UDI
- Device Name
- PENILE PROSTHESIS PACK FDA UDI
- Model / Reference
- SOTCNPPMEA FDA UDI
- Description
- PENILE PROSTHESIS PACK FDA UDI
Identifiers
- Catalog Number
- SOTCNPPMEA FDA UDI
- Primary DI / UDI-DI
- 10197106662397 FDA UDI
- GMDN Term
- Urological surgical procedure kit, non-medicated, single-use FDA UDI
Classification
- 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: Urological surgical procedure kit, non-medicated, single-use
Cardinal Health by Cardinal Health 200, LLC — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- CARDINAL HEALTH — Cardinal Health 200, LLC · Class II
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | N/A | Pending data |
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Manufacturer
- Manufacturer
- Cardinal Health 200, LLC
Sources (1)
- FDA UDI 07d8d566-f0d8-4df5-a108-8ac0fb515002 35 fields · synced Jun 8, 2026