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Urethrotomy bridge

FDA UDI

Class II (US FDA UDI)

by SOPRO-COMEG GmbH

Identity

Trade Name
Urethrotomy bridge FDA UDI
Generic Name
Endoscope assembly adaptor FDA UDI
Model / Reference
199 115 200BC FDA UDI

Identifiers

Primary DI / UDI-DI
04059082011004 FDA UDI
510(k) Number
K971881 FDA UDI
FDA Product Code
EZO FDA UDI
GMDN Term
Endoscope assembly adaptor FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.4770 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

No

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: Endoscope assembly adaptor

Urethrotomy bridge by SOPRO-COMEG GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Endoscope assembly adaptor.

Cleared under the same submission

K971881 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
SOPRO-COMEG GmbH

Sources (1)

  • FDA UDI e21ba2b4-d3bf-4cee-b1bb-b5bb0fb1ce1a 33 fields · synced May 30, 2026