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Monarch® Iii

FDA UDI

Class I (US FDA UDI)

by Alcon Laboratories, Inc.

Identity

Trade Name
MONARCH® III FDA UDI
Generic Name
Manual intraocular lens injector, reusable FDA UDI
Device Name
MONARCH III IOL DELIVERY SYSTEM, INJECTOR FDA UDI
Model / Reference
8065977773 FDA UDI
Description
MONARCH III IOL DELIVERY SYSTEM, INJECTOR FDA UDI

Identifiers

Primary DI / UDI-DI
00380659777738 FDA UDI
FDA Product Code
KYB 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Manual intraocular lens injector, reusable

Monarch® Iii by Alcon Laboratories, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Manual intraocular lens injector, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Alcon Laboratories, Inc.

Sources (1)

  • FDA UDI f5945880-66d0-43a0-8fd0-ae5e70c42f41 34 fields · synced May 31, 2026