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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
FOOT-SWITCHING MONOPOLAR FORCEPS: CUSHING, SERRATED, STRAIGHT TIP, TOUCH TYPE STAINLESS STEEL CONTACT. INDICATE: LIST NO. 5XXX-XX + TIP SIZE FDA UDI
Model / Reference
5414-10B-M FDA UDI
Description
FOOT-SWITCHING MONOPOLAR FORCEPS: CUSHING, SERRATED, STRAIGHT TIP, TOUCH TYPE STAINLESS STEEL CONTACT. INDICATE: LIST NO. 5XXX-XX + TIP SIZE FDA UDI

Identifiers

Catalog Number
5414-10B-M FDA UDI
Primary DI / UDI-DI
00842180178243 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 c6b39d64-ef7e-4c70-8ed2-8ae06ccf18da 35 fields · synced May 30, 2026