Identity
- Trade Name
- SpeediCath Compact FDA UDI
- Generic Name
- Single-administration urethral drainage catheter FDA UDI
- Device Name
- SpeediCath Compact. Urinary catheter for intermittent catheterization. Ready to use coated catheter. Nelaton. Male. FR 12/4.0-18/6.0 mm. Rx Only. FDA UDI
- Model / Reference
- 28692 FDA UDI
- Description
- SpeediCath Compact. Urinary catheter for intermittent catheterization. Ready to use coated catheter. Nelaton. Male. FR 12/4.0-18/6.0 mm. Rx Only. FDA UDI
Identifiers
- Catalog Number
- 28692 FDA UDI
- Primary DI / UDI-DI
- 05708932579032 FDA UDI
- 510(k) Number
- K210250 FDA UDI
- FDA Product Code
- GBM FDA UDI
- GMDN Term
- Single-administration urethral drainage catheter FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5130 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
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 — 12 French FDA UDIOuter Diameter — 4 Millimeter FDA UDI
SpeediCath Compact by Coloplast A/S — Class II — 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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Coloplast A/S
Sources (1)
- FDA UDI 16da4541-e771-4d81-84f5-e3893776664d 39 fields · synced May 30, 2026