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USA Elite

FDA UDI

Class II (US FDA UDI)

by Gyrus Acmi, Inc.

Identity

Trade Name
USA Elite FDA UDI
Generic Name
Rigid endoscopic stone-retrieval forceps, reusable FDA UDI
Device Name
USA Elite System Rigid Optical Stone Crushing Forceps FDA UDI
Model / Reference
E8217 FDA UDI
Description
USA Elite System Rigid Optical Stone Crushing Forceps FDA UDI

Identifiers

Primary DI / UDI-DI
00821925001268 FDA UDI
FDA Product Code
FGO FDA UDI
GMDN Term
Rigid endoscopic stone-retrieval forceps, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.4680 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: Rigid endoscopic stone-retrieval forceps, reusable

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

Similar devices

Also classified as Rigid endoscopic stone-retrieval forceps, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Gyrus Acmi, Inc.

Sources (1)

  • FDA UDI 030a60fe-8798-4e24-a460-c756f2b9d53d 33 fields · synced May 30, 2026