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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 handpiece/electrode, monopolar, reusable FDA UDI
Device Name
ELMED FRAZIER MONOPOLAR SUCTION COAGULATOR, ANGULAR, INSULATED, W/ RF-CONNECTOR, 12" (305 MM), REUSABLE, 9 FR DIA FDA UDI
Model / Reference
37-5012-09 FDA UDI
Description
ELMED FRAZIER MONOPOLAR SUCTION COAGULATOR, ANGULAR, INSULATED, W/ RF-CONNECTOR, 12" (305 MM), REUSABLE, 9 FR DIA FDA UDI

Identifiers

Catalog Number
37-5012-09 FDA UDI
Primary DI / UDI-DI
00842180121829 FDA UDI
FDA Product Code
GEI FDA UDI
GMDN Term
Open-surgery electrosurgical handpiece/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

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: Open-surgery electrosurgical handpiece/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 handpiece/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 b1659ada-ed34-4252-aa84-56c3c9849e5c 35 fields · synced May 31, 2026