Gyrus ACMI

FDA UDI

Class I (US FDA UDI)

by Gyrus Acmi, Inc.

Identity

Trade Name: Gyrus ACMI FDA UDI
Generic Name: Surgical cutting/shaping board, reusable FDA UDI
Device Name: AUSTIN SURGICAL CUTTING BLOCK FDA UDI
Model / Reference: 130130 FDA UDI
Description: AUSTIN SURGICAL CUTTING BLOCK FDA UDI

Identifiers

Primary DI / UDI-DI: 00821925013261 FDA UDI
FDA Product Code: JXY FDA UDI
GMDN Term: Surgical cutting/shaping board, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 874.3540 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: Surgical cutting/shaping board, reusable

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

Similar devices

Also classified as Surgical cutting/shaping board, reusable.

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Fisch cutting and preparation jig — Spiggle & Theis Medizintechnik GmbH · Class I
MSI Precision Specialty Instruments — Med Saver, Inc. · Class I
MILLENNIUM — AVALIGN TECHNOLOGIES, Inc. · Class I
Marina Medical — MARINA MEDICAL INSTRUMENTS, INC. · Class I
Preparation tray, stainless steel — Spiggle & Theis Medizintechnik GmbH · Class I
V. Mueller — STERIS CORPORATION · Class I
Graft Processing Board — COLE INSTRUMENTS · 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 I	Pending data

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Manufacturer

Manufacturer: Gyrus Acmi, Inc.

Sources (1)

FDA UDI e96597a3-9571-4c4a-902d-51d611879573 33 fields · synced May 30, 2026