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Elmed

FDA UDI

Class II (US FDA UDI)

by Elmed Incorporated

Identity

Trade Name
ELMED FDA UDI
Generic Name
Open-surgery electrosurgical electrode, monopolar, reusable FDA UDI
Device Name
150MM SHAFT LENGTH, 4MM (3/16") DIA. SHAFT, 2MM DIA. COAGULATING BALL ELECTRODE STRAIGHT, INSULATED FOR USE W/ELMED AND ERBE HANDLES FDA UDI
Model / Reference
5820-10 FDA UDI
Description
150MM SHAFT LENGTH, 4MM (3/16") DIA. SHAFT, 2MM DIA. COAGULATING BALL ELECTRODE STRAIGHT, INSULATED FOR USE W/ELMED AND ERBE HANDLES FDA UDI

Identifiers

Catalog Number
5820-10 FDA UDI
Primary DI / UDI-DI
00842180125933 FDA UDI
FDA Product Code
GEI FDA UDI
GMDN Term
Open-surgery 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

Yes

FDA UDI

Lot / Batch Number

No

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: Open-surgery 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 Open-surgery electrosurgical electrode, monopolar, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Elmed Incorporated

Sources (1)

  • FDA UDI 956042ac-8913-4f6c-91cf-f94b376f5b93 35 fields · synced Jun 8, 2026