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Elmed

FDA UDI

Class II (US FDA UDI)

by Elmed Incorporated

Identity

Trade Name
ELMED FDA UDI
Generic Name
Electrosurgical system generator FDA UDI
Device Name
ELMED BC 50 M/M AUTOMATIC BIPOLAR COAGULATOR, SMART-O-MATIC CIRCUIT, MICRO AND MACRO OUTPUT, FOOTSWITCHING, AUTOMATIC AND HANDSWITCHING (BI-CO-MATIC) (SELECT ACCESSORIES AS REQUIRED) FDA UDI
Model / Reference
5299 FDA UDI
Description
ELMED BC 50 M/M AUTOMATIC BIPOLAR COAGULATOR, SMART-O-MATIC CIRCUIT, MICRO AND MACRO OUTPUT, FOOTSWITCHING, AUTOMATIC AND HANDSWITCHING (BI-CO-MATIC) (SELECT ACCESSORIES AS REQUIRED) FDA UDI

Identifiers

Catalog Number
5299 FDA UDI
Primary DI / UDI-DI
00842180105935 FDA UDI
FDA Product Code
BWA FDA UDI
GMDN Term
Electrosurgical system generator 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

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Electrosurgical system generator

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

Similar devices

Also classified as Electrosurgical system generator.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Elmed Incorporated

Sources (1)

  • FDA UDI 792fc012-5211-4a5f-8f7e-73102146059e 35 fields · synced Jun 1, 2026