Identity
- Trade Name
- GentleCath Hydrophilic FDA UDI
- Generic Name
- Single-administration urethral catheterization kit, single-use FDA UDI
- Device Name
- Hydrophilic Intermittent Urinary Catheter With Water Sachet Female 8'' 16FR FDA UDI
- Model / Reference
- 508992 FDA UDI
- Description
- Hydrophilic Intermittent Urinary Catheter With Water Sachet Female 8'' 16FR FDA UDI
Identifiers
- Catalog Number
- 508992 FDA UDI
- Primary DI / UDI-DI
- 07333387031576 FDA UDI
- FDA Product Code
- EZD 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
No
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
Dimensions & Sizes
- Size
- Catheter Gauge — 16 French FDA UDILength — 8 Inch FDA UDI
Category: Single-administration urethral catheterization kit, single-use
GentleCath Hydrophilic 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.
- OneCath — COMPACTCATH, INC · Class II
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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 1766b75c-044f-4f96-8bc9-9087fbd838d5 37 fields · synced Jun 1, 2026