Identity
- Trade Name
- SimPro™ Set FDA UDI
- Generic Name
- Single-administration urethral catheterization kit, single-use FDA UDI
- Device Name
- Single Use Urinary Catheter with water sachet and Accessories. Coudé 16" 16FR FDA UDI
- Model / Reference
- 5351600 FDA UDI
- Description
- Single Use Urinary Catheter with water sachet and Accessories. Coudé 16" 16FR FDA UDI
Identifiers
- Catalog Number
- 5351600 FDA UDI
- Primary DI / UDI-DI
- 07333387043883 FDA UDI
- FDA Product Code
- FAQ FDA UDIEYY FDA UDINWO FDA UDILYZ FDA UDIEZD FDA UDI
- GMDN Term
- Single-administration urethral catheterization kit, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 876.5250 FDA UDI878.4370 FDA UDI876.5130 FDA UDI880.6250 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 — 16 French FDA UDILength — 16 Inch FDA UDI
Category: Single-administration urethral catheterization kit, single-use
SimPro™ Set by Wellspect AB — Class I — 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
- 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
- MTG EZ-Advancer® — 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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Wellspect AB
Sources (1)
- FDA UDI 1f247227-3191-40c9-83d6-31f211261c74 37 fields · synced May 31, 2026