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Gyrus ACMI

FDA UDI

Class I (US FDA UDI)

by Gyrus Acmi, Inc.

Identity

Trade Name
Gyrus ACMI FDA UDI
Generic Name
Flexible endoscopic scissors, reusable FDA UDI
Device Name
Flexible Scissors 5 Fr (1.67mm), 58 CM FDA UDI
Model / Reference
FS-558 FDA UDI
Description
Flexible Scissors 5 Fr (1.67mm), 58 CM FDA UDI

Identifiers

Primary DI / UDI-DI
00821925008960 FDA UDI
FDA Product Code
LRW FDA UDI
GMDN Term
Flexible endoscopic scissors, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4800 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

Yes

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
Ethylene Oxide FDA UDI

Category: Flexible endoscopic scissors, reusable

Gyrus ACMI by Gyrus Acmi, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Flexible endoscopic scissors, 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 c57e1ddd-f6ef-4fcb-817a-aa6580d65d55 33 fields · synced May 30, 2026