I9012

FDA UDI

Class I (US FDA UDI)

by Lenstec Barbados Inc

Identity

Trade Name: I9012 FDA UDI
Generic Name: Manual intraocular lens injector, reusable FDA UDI
Device Name: Threaded Injector, Course Thread, Large Knob, Titanium FDA UDI
Model / Reference: 05-2136-B FDA UDI
Description: Threaded Injector, Course Thread, Large Knob, Titanium FDA UDI

Identifiers

Primary DI / UDI-DI: 00844369016865 FDA UDI
FDA Product Code: MSS FDA UDI
GMDN Term: Manual intraocular lens injector, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 886.4300 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

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

Category: Manual intraocular lens injector, reusable

I9012 by Lenstec Barbados Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Lenstec Barbados Inc

Sources (1)

FDA UDI 65e6bd69-6e9e-4d8b-8787-657bb12d6350 33 fields · synced May 30, 2026