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Elmed

FDA UDI

Class II (US FDA UDI)

by Elmed Incorporated

Identity

Trade Name
ELMED FDA UDI
Generic Name
Surgical optical-tracking spatial marker holder FDA UDI
Device Name
ELMED ESU 170 U ELECTROSURGICAL UNIT, SMART-O-MATIC CIRCUIT, MONOPOLAR AND BIPOLAR, FOOTSWITCHING AND HANDSWITCHING (BI-CO-MATIC) FDA UDI
Model / Reference
5695 FDA UDI
Description
ELMED ESU 170 U ELECTROSURGICAL UNIT, SMART-O-MATIC CIRCUIT, MONOPOLAR AND BIPOLAR, FOOTSWITCHING AND HANDSWITCHING (BI-CO-MATIC) FDA UDI

Identifiers

Catalog Number
5695 FDA UDI
Primary DI / UDI-DI
00842180179219 FDA UDI
FDA Product Code
GEI FDA UDI
GMDN Term
Surgical optical-tracking spatial marker holder 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: Surgical optical-tracking spatial marker holder

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

Similar devices

Also classified as Surgical optical-tracking spatial marker holder.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Elmed Incorporated

Sources (1)

  • FDA UDI 7866f426-35b6-4052-b831-32ea286e7616 35 fields · synced May 30, 2026