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Marina Medical

FDA UDI

Class I (US FDA UDI)

by Marina Medical Instruments, Inc.

Identity

Trade Name
Marina Medical FDA UDI
Generic Name
Ophthalmic surgical irrigation/infusion/aspiration handle, reusable FDA UDI
Device Name
Infusion Handle with on/off control valve FDA UDI
Model / Reference
800-163 FDA UDI
Description
Infusion Handle with on/off control valve FDA UDI

Identifiers

Catalog Number
800-163 FDA UDI
Primary DI / UDI-DI
00840306809705 FDA UDI
FDA Product Code
KGZ FDA UDI
GMDN Term
Ophthalmic surgical irrigation/infusion/aspiration handle, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4200 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

No

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

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI
MRI Safety
MR Safe FDA UDI

Category: Ophthalmic surgical irrigation/infusion/aspiration handle, reusable

Marina Medical by Marina Medical Instruments, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ophthalmic surgical irrigation/infusion/aspiration handle, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Marina Medical Instruments, Inc.

Sources (1)

  • FDA UDI 4ff6a75b-5d51-42a3-a344-a6015753713c 35 fields · synced May 30, 2026