Elmed Incorporated

FDA UDI

Class II (US FDA UDI)

by Elmed Incorporated

Identity

Trade Name: ELMED INCORPORATED FDA UDI
Generic Name: Laparoscopic surgery handle FDA UDI
Device Name: TYPE 17 - REPLACEMENT LIGHTWEIGHT CARBON FIBER W/ RF POST FDA UDI
Model / Reference: ST525554017 FDA UDI
Description: TYPE 17 - REPLACEMENT LIGHTWEIGHT CARBON FIBER W/ RF POST FDA UDI

Identifiers

Catalog Number: ST525554017 FDA UDI
Primary DI / UDI-DI: 00198506080531 FDA UDI
FDA Product Code: GEI FDA UDI
GMDN Term: Laparoscopic surgery handle 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Laparoscopic surgery handle

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

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Elmed Incorporated

Sources (1)

FDA UDI ad9d668f-705d-4d62-b430-63590bf2dbda 35 fields · synced Jun 6, 2026