Inami Ophthalmic Instruments

FDA UDI

Class I (US FDA UDI)

by Inami & Co., Ltd.

Identity

Trade Name: Inami Ophthalmic Instruments FDA UDI
Generic Name: Trabeculotome, reusable FDA UDI
Device Name: MATSUSHITA edition. ver.2, Tanito ab interno Trabeculotomy Micro-hook, Left FDA UDI
Model / Reference: M-2221L FDA UDI
Description: MATSUSHITA edition. ver.2, Tanito ab interno Trabeculotomy Micro-hook, Left FDA UDI

Identifiers

Primary DI / UDI-DI: 04547451338635 FDA UDI
FDA Product Code: HNK FDA UDI
GMDN Term: Trabeculotome, 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

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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Trabeculotome, reusable

Inami Ophthalmic Instruments by Inami & Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Trabeculotome, reusable.

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Wexler Surgical, Inc. — Wexler Surgical, Inc. · Class I
Bausch + Lomb — Bausch & Lomb Incorporated · Class I
Trab Probe — Katena Products, Inc. · Class I
MSI Precision Specialty Instruments — Med Saver, Inc. · Class I
MSI Precision Specialty Instruments — Med Saver, 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: Inami & Co., Ltd.

Sources (1)

FDA UDI 0fbb3652-96a9-4d44-8600-9be5ab209dfa 33 fields · synced Jun 6, 2026