Identity
- Trade Name
- Porges Coloplast FDA UDI
- Generic Name
- Ureteral catheter FDA UDI
- Device Name
- Floppy Tip Hydro-Coated Ureteric Catheter for guidewire 0.035" (0.89mm)/ 70 cm / CH/FR 07 FDA UDI
- Model / Reference
- ACR207 FDA UDI
- Description
- Floppy Tip Hydro-Coated Ureteric Catheter for guidewire 0.035" (0.89mm)/ 70 cm / CH/FR 07 FDA UDI
Identifiers
- Catalog Number
- ACR207 FDA UDI
- Primary DI / UDI-DI
- 03600040324202 FDA UDI
- FDA Product Code
- EYB FDA UDI
- GMDN Term
- Ureteral catheter 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 — 7 French FDA UDI
Category: Ureteral catheter
Porges Coloplast by Coloplast A/S — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ureteral catheter.
- Bard® Polyurethane Ureteral Catheters, Open Tip — C. R. Bard, Inc. · Class II
- Ureteral Catheter — Well Lead Medical Co., Ltd · Class II
- Bard® Woven Ureteral Catheter — C. R. Bard, Inc. · Class II
- Novo Surgical — NOVO SURGICAL, INC. · Class I
- Ureteral Catheter — Well Lead Medical Co., Ltd · Class II
- UroForce® Balloon Dilation Catheter — C. R. Bard, Inc. · Class II
- Metal Catheter — RZ-Medizintechnik GmbH · Class I
- Bard® X-Force® Balloon Dilation Catheter — C. R. Bard, Inc. · 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
- Coloplast A/S
Sources (1)
- FDA UDI 1d5a2689-ec93-498a-95af-81ad4cf8e78c 37 fields · synced Jun 8, 2026