MANI Trocar Kit

FDA UDI

Class I (US FDA UDI)

by Mani, Inc.

Identity

Trade Name: MANI Trocar Kit FDA UDI
Generic Name: Ophthalmic cannulation set, single-use FDA UDI
Device Name: MANI Trocar Kit FDA UDI
Model / Reference: MTK23S TROCAR KIT 23G S FDA UDI
Description: MANI Trocar Kit FDA UDI

Identifiers

Primary DI / UDI-DI: 14546951403963 FDA UDI
FDA Product Code: NGY FDA UDI
GMDN Term: Ophthalmic cannulation set, single-use 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

Yes

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Ophthalmic cannulation set, single-use

MANI Trocar Kit by Mani, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ophthalmic cannulation set, single-use.

Disposable One Step Cannula System (25 gauge/0.5 mm) — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. · Class I
Surgeon's Choice Card — OASIS Medical, Inc. · Class I
Kaiser Permanente Kit Pack — OASIS Medical, Inc. · Class I
ALCON — Alcon Laboratories, Inc. · Class I
23G Cannula set with High Flow infusion line — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. · Class I
Disposable one step single cannula including inserter. (27 gauge / 0.4 mm) — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. · Class I
Kaiser Permanente Kit Pack — OASIS Medical, Inc. · Class I
25G High Flow infusion line — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. · 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: Mani, Inc.

Sources (1)

FDA UDI da4981d1-8b19-4f44-bdec-6b2ec7667dde 33 fields · synced May 29, 2026