Identity
- Trade Name
- SUPRA-FOLEY FDA UDI
- Generic Name
- Suprapubic catheterization kit FDA UDI
- Device Name
- Suprapubic Catheter Introducer Kit, 14 French FDA UDI
- Model / Reference
- 14Fr Catheterization Kit FDA UDI
- Description
- Suprapubic Catheter Introducer Kit, 14 French FDA UDI
Identifiers
- Catalog Number
- SF-S14-104 FDA UDI
- Primary DI / UDI-DI
- H671SFS141040 FDA UDI
- 510(k) Number
- K884061 FDA UDI
- FDA Product Code
- KOB FDA UDI
- GMDN Term
- Suprapubic catheterization kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5090 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Catheter Gauge — 14 French FDA UDI
Category: Suprapubic catheterization kit
Supra-Foley by Utah Medical Products, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Suprapubic catheterization kit.
- SUPRA-FOLEY — Utah Medical Products, Inc. · Class II
- SUPRA-FOLEY — Utah Medical Products, Inc. · Class II
Cleared under the same submission
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 | Class II | Pending data |
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Manufacturer
- Manufacturer
- Utah Medical Products, Inc.
Sources (1)
- FDA UDI 7b44b386-c514-4ad7-8fe1-69d09c9d8236 37 fields · synced Jun 9, 2026