← Back to catalogue

Dormia

FDA UDI

Class II (US FDA UDI)

by Coloplast A/S

Identity

Trade Name
Dormia FDA UDI
Generic Name
Urinary stone retrieval basket, single-use FDA UDI
Model / Reference
EXN434 FDA UDI

Identifiers

Catalog Number
EXN434 FDA UDI
Primary DI / UDI-DI
03600040955468 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 — 3 French FDA UDI
Length — 90 Centimeter FDA UDI

Category: Urinary stone retrieval basket, single-use

Dormia 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.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Coloplast A/S

Sources (1)

  • FDA UDI 86e99ead-7887-4987-bff9-9a4fdf2f44ca 36 fields · synced Jun 8, 2026