Identity
- Trade Name
- United Urologics Closed System Catheter Kit FDA UDI
- Generic Name
- Single-administration urethral catheterization kit, single-use FDA UDI
- Model / Reference
- UU16RK FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00818016020253 FDA UDI
- FDA Product Code
- KOD FDA UDI
- GMDN Term
- Single-administration urethral catheterization kit, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5130 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
Yes
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
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
Category: Single-administration urethral catheterization kit, single-use
United Urologics Closed System Catheter Kit by United Urologics Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Single-administration urethral catheterization kit, single-use.
- OneCath — COMPACTCATH, INC · Class II
- MTG EZ-Advancer® Mini-Pak — Medical Technologies of Georgia · Class II
- SureCath — Coloplast A/S · Class II
- LoFric® Hydro-Kit™ — Wellspect AB · Class II
- Medline — MEDLINE INDUSTRIES, INC. · Class II
- COMPACTCATH — COMPACTCATH, INC · Class II
- VaPro Plus Pocket Kit — Hollister Incorporated · Class II
- MTG EZ-Gripper® Long — Medical Technologies of Georgia · 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 | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- United Urologics Inc
Sources (1)
- FDA UDI 91e9c7ed-fa8b-4c99-810a-0f61a35c17c2 32 fields · synced May 30, 2026