Identity
- Trade Name
- Dila-Cath Nelaton 40cm CH16 FDA UDI
- Generic Name
- Urethral dilatation catheter, non-medicated FDA UDI
- Device Name
- Urinary catheter for intermittent dilatation FDA UDI
- Model / Reference
- 40616 FDA UDI
- Description
- Urinary catheter for intermittent dilatation FDA UDI
Identifiers
- Catalog Number
- 4061600 FDA UDI
- Primary DI / UDI-DI
- 07392532131707 FDA UDI
- FDA Product Code
- FBX FDA UDI
- GMDN Term
- Urethral dilatation catheter, non-medicated FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 876.5520 FDA UDI
- Commercial Distribution
- Not 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
Yes
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 — 40 Centimeter FDA UDICatheter Gauge — 16 French FDA UDI
Dila-Cath Nelaton 40cm CH16 by Wellspect AB — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 |
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Manufacturer
- Manufacturer
- Wellspect AB
Sources (1)
- FDA UDI b186522b-e857-4987-85cc-47a8b55a0d7a 38 fields · synced Jun 1, 2026