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Gyrus ACMI

FDA UDI

Class II (US FDA UDI)

by Gyrus Acmi, Inc.

Identity

Trade Name
Gyrus ACMI FDA UDI
Generic Name
Rigid endoscopic stone-retrieval forceps, reusable FDA UDI
Device Name
Rigid Alligator Grasping Forceps Serrated Alligator Jaws 3 mm (9 Fr), 37 cm FDA UDI
Model / Reference
RAG-337R FDA UDI
Description
Rigid Alligator Grasping Forceps Serrated Alligator Jaws 3 mm (9 Fr), 37 cm FDA UDI

Identifiers

Primary DI / UDI-DI
00821925007468 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

Gyrus ACMI 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 1cc3857a-1b96-493b-a405-6d9f3600144a 33 fields · synced May 30, 2026