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Electrode

FDA UDI

Class II (US FDA UDI)

by SOPRO-COMEG GmbH

Identity

Trade Name
Electrode FDA UDI
Generic Name
Open-surgery electrosurgical handpiece/electrode, monopolar, reusable FDA UDI
Model / Reference
195 100 051 FDA UDI

Identifiers

Primary DI / UDI-DI
04059082031057 FDA UDI
510(k) Number
K971881 FDA UDI
FDA Product Code
FAS FDA UDI
GMDN Term
Open-surgery electrosurgical handpiece/electrode, monopolar, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.4300 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

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Open-surgery electrosurgical handpiece/electrode, monopolar, reusable

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

Similar devices

Also classified as Open-surgery electrosurgical handpiece/electrode, monopolar, reusable.

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 3425769c-fe9f-4f13-b978-5c98455ed0cc 33 fields · synced Jun 8, 2026