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Porges Coloplast

FDA UDI

Class II (US FDA UDI)

by Coloplast A/S

Identity

Trade Name
Porges Coloplast FDA UDI
Generic Name
Urinary stone retrieval basket, single-use FDA UDI
Device Name
DORMIA® Stone extractors with an "extractible basket" FDA UDI
Model / Reference
EFP624 FDA UDI
Description
DORMIA® Stone extractors with an "extractible basket" FDA UDI

Identifiers

Catalog Number
EFP624 FDA UDI
Primary DI / UDI-DI
03600040229729 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
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

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 — 2.5 French FDA UDI

The Porges Coloplast is a manual endotherapy instrument designed to safely and effectively remove urinary stones from the kidneys or ureters, making it an essential tool for urologists and patients alike. This device has been engineered with precision and care, ensuring accurate placement of the basket and optimal stone retrieval. With its innovative design and user-friendly handle, the Porges Coloplast is a valuable asset in the fight against urinary stones.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Coloplast A/S

Sources (1)

  • FDA UDI 1f6e3b97-d5c0-45ce-9233-a6412dab7327 38 fields · synced Jul 24, 2026