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Elmed

FDA UDI

Class II (US FDA UDI)

by Elmed Incorporated

Identity

Trade Name
ELMED FDA UDI
Generic Name
Endoscopic electrosurgical electrode, monopolar, reusable FDA UDI
Device Name
Flexible Monopolar Coagulation Electrode, Ball Electrode FDA UDI
Model / Reference
31845-01 FDA UDI
Description
Flexible Monopolar Coagulation Electrode, Ball Electrode FDA UDI

Identifiers

Catalog Number
31845-01 FDA UDI
Primary DI / UDI-DI
00842180166059 FDA UDI
510(k) Number
K915731 FDA UDI
FDA Product Code
GEI FDA UDI
GMDN Term
Endoscopic electrosurgical electrode, monopolar, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4400 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: Endoscopic electrosurgical electrode, monopolar, reusable

Elmed by Elmed Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Endoscopic electrosurgical electrode, monopolar, reusable.

Cleared under the same submission

K915731 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Elmed Incorporated

Sources (1)

  • FDA UDI 8975f658-bc14-4188-b77c-05007d38029c 36 fields · synced Jun 1, 2026