Identity
- Trade Name
- GentleCath Hydrophilic Kit FDA UDI
- Generic Name
- Single-administration urethral catheterization kit, single-use FDA UDI
- Device Name
- Hydrophilic Intermittent Urinary Catheter With Water Sachet And Insertion Kit Female 8'' 12FR FDA UDI
- Model / Reference
- 509006 FDA UDI
- Description
- Hydrophilic Intermittent Urinary Catheter With Water Sachet And Insertion Kit Female 8'' 12FR FDA UDI
Identifiers
- Catalog Number
- 509006 FDA UDI
- Primary DI / UDI-DI
- 07333387043975 FDA UDI
- FDA Product Code
- NWO FDA UDIEZD FDA UDIEYY FDA UDILYZ FDA UDIFAQ 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 UDI878.4370 FDA UDI880.6250 FDA UDI876.5250 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
- Length — 8 Inch FDA UDICatheter Gauge — 12 French FDA UDI
Category: Single-administration urethral catheterization kit, single-use
GentleCath Hydrophilic Kit by Wellspect AB — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Single-administration urethral catheterization kit, single-use.
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- 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 II | Pending data |
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Manufacturer
- Manufacturer
- Wellspect AB
Sources (1)
- FDA UDI 14c9975b-569f-41ad-8461-8e39e2de3ce9 37 fields · synced Jun 1, 2026