USA Elite

FDA UDI

Class II (US FDA UDI)

by Gyrus Acmi, Inc.

Identity

Trade Name: USA Elite FDA UDI
Generic Name: Urethrotome FDA UDI
Device Name: USA Elite System and USA Series Cold Knife, Serrated Blade FDA UDI
Model / Reference: K-SE FDA UDI
Description: USA Elite System and USA Series Cold Knife, Serrated Blade FDA UDI

Identifiers

Primary DI / UDI-DI: 00821925002678 FDA UDI
FDA Product Code: EZO FDA UDI
GMDN Term: Urethrotome FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.4770 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

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

Ethylene Oxide FDA UDI

Category: Urethrotome

USA Elite by Gyrus Acmi, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Medicon — Medicon eG. Chirurgiemechaniker-Genossenschaft · Class II
Greenwald Surgical Company, Inc. — GRACE MANUFACTURING INC · Class II
RZ Medizintechnik GmbH — RZ-Medizintechnik GmbH · Class I

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: Gyrus Acmi, Inc.

Sources (1)

FDA UDI f18be898-e558-4613-89ee-43363af725a3 33 fields · synced May 30, 2026