← Back to catalogue

Trokamed

FDA UDI

Class II (US FDA UDI)

by TROKAMED GmbH

Identity

Trade Name
Trokamed FDA UDI
Generic Name
Urethrotome FDA UDI
Device Name
Cold knife, half round FDA UDI
Model / Reference
UUM00198 FDA UDI
Description
Cold knife, half round FDA UDI

Identifiers

Catalog Number
UUM00198 FDA UDI
Primary DI / UDI-DI
04251303817659 FDA UDI
FDA Product Code
GCJ FDA UDI
GMDN Term
Urethrotome FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.1500 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Urethrotome

Trokamed by TROKAMED GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Urethrotome.

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
TROKAMED GmbH

Sources (1)

  • FDA UDI 1accbd0a-2792-4cf2-addc-f9cd39764c06 35 fields · synced Jun 1, 2026