Identity
- Trade Name
- Porges Coloplast FDA UDI
- Generic Name
- Endoscopic-access dilator, single-use FDA UDI
- Device Name
- In-Ka Ureteral Balloon Dilatation Catheter + syringe Balloon Dilation with inflation device, diameter of the balloon 5 mm, body tube length 75 cm, radiopaque stainless-steel rings + Syringe 10 ml FDA UDI
- Model / Reference
- BD4145 FDA UDI
- Description
- In-Ka Ureteral Balloon Dilatation Catheter + syringe Balloon Dilation with inflation device, diameter of the balloon 5 mm, body tube length 75 cm, radiopaque stainless-steel rings + Syringe 10 ml FDA UDI
Identifiers
- Catalog Number
- BD4145 FDA UDI
- Primary DI / UDI-DI
- 05708932727532 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
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 — 75 Centimeter FDA UDIOuter Diameter — 5 Millimeter 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
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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
- Coloplast A/S
Sources (1)
- FDA UDI f610edb1-f0f9-4b6b-952c-37d186cf65d1 37 fields · synced May 30, 2026