Identity
- Trade Name
- Porges Coloplast FDA UDI
- Generic Name
- Urinary stone retrieval basket, single-use FDA UDI
- Device Name
- DORMIA® Stone extractor 4 CH/FR with an "extractible basket" FDA UDI
- Model / Reference
- DOR214 FDA UDI
- Description
- DORMIA® Stone extractor 4 CH/FR with an "extractible basket" FDA UDI
Identifiers
- Catalog Number
- DOR214 FDA UDI
- Primary DI / UDI-DI
- 03600040226773 FDA UDI
- FDA Product Code
- FFL FDA UDI
- GMDN Term
- Urinary stone retrieval basket, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.4680 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
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
- Catheter Gauge — 4 French FDA UDI
Category: Urinary stone retrieval basket, 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 Urinary stone retrieval basket, single-use.
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- GYRUS ACMI — Gyrus Acmi, Inc. · Class II
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- Dornier MedTech — Dornier MedTech America, Inc. · Class II
- Dornier MedTech — Dornier MedTech America, 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 25c1d46c-1bd8-4f12-be2d-764c52079cd1 37 fields · synced May 30, 2026