Accutome Surgical

FDA UDI

Class I (US FDA UDI)

by Microsurgical Technology, Inc.

Identity

Trade Name: Accutome Surgical FDA UDI
Generic Name: Ocular hook/spatula/manipulator, reusable FDA UDI
Device Name: Machat / Sinskey Lasik Spatula Double-Ended FDA UDI
Model / Reference: AH1115 FDA UDI
Description: Machat / Sinskey Lasik Spatula Double-Ended FDA UDI

Identifiers

Catalog Number: AH1115 FDA UDI
Primary DI / UDI-DI: 00844685006472 FDA UDI
FDA Product Code: HND FDA UDI
GMDN Term: Ocular hook/spatula/manipulator, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 886.4350 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

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Ocular hook/spatula/manipulator, reusable

Accutome Surgical by Microsurgical Technology, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Ocular hook/spatula/manipulator, reusable.

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Ophthalmic Spatula — CILITA Ltd. · Class I
Rumex — Rumex International Co. · Class I
Sklar — Sklar Corporation · Class I
Surgical Direct — SURGICAL DIRECT, INC. · 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: Microsurgical Technology, Inc.

Sources (1)

FDA UDI 2ed5c018-6faa-43be-bf9f-b15f693bc580 34 fields · synced May 30, 2026