Identity
- Trade Name
- Porges Coloplast FDA UDI
- Generic Name
- Endoscopic-access dilator, single-use FDA UDI
- Device Name
- Percutaneous nephrostomy dilator CH FR 12 FDA UDI
- Model / Reference
- RBA012 FDA UDI
- Description
- Percutaneous nephrostomy dilator CH FR 12 FDA UDI
Identifiers
- Catalog Number
- RBA012 FDA UDI
- Primary DI / UDI-DI
- 03600040255827 FDA UDI
- FDA Product Code
- EZN FDA UDI
- GMDN Term
- Endoscopic-access dilator, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5470 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 — 12 French FDA UDI
Category: Endoscopic-access dilator, single-use
Porges Coloplast by Coloplast A/S — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endoscopic-access dilator, single-use.
- Cardiovascular Procedure Kit — Terumo Cardiovascular Systems Corporation · Class II
- Cardiovascular Procedure Kit — Terumo Cardiovascular Systems Corporation · Class II
- Cardiovascular Procedure Kit — Terumo Cardiovascular Systems Corporation · Class II
- O'Brien — COOK INCORPORATED · Class II
- Cardiovascular Procedure Kit — Terumo Cardiovascular Systems Corporation · Class II
- CONMED CleanGuide — Jiangsu Grit Medical Technology Co., Ltd. · Class II
- Cook — COOK INCORPORATED · Class II
- Cook — COOK INCORPORATED · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Coloplast A/S
Sources (1)
- FDA UDI b3aa7b16-6945-4fa5-bb18-1b86a12161ea 37 fields · synced Jun 8, 2026