Marina Medical

FDA UDI

Class I (US FDA UDI)

by Marina Medical Instruments, Inc.

Identity

Trade Name: Marina Medical FDA UDI
Generic Name: Suturing needle holder, reusable FDA UDI
Device Name: Olsen-Hegar Needle Holder, Straight, Serrated, TC, 17cm FDA UDI
Model / Reference: 420-917 FDA UDI
Description: Olsen-Hegar Needle Holder, Straight, Serrated, TC, 17cm FDA UDI

Identifiers

Catalog Number: 420-917 FDA UDI
Primary DI / UDI-DI: 00840306809156 FDA UDI
FDA Product Code: HXK FDA UDI
GMDN Term: Suturing needle holder, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.4540 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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

MRI Safety

MR Safe FDA UDI

Dimensions & Sizes

Size: Length — 17 Centimeter FDA UDI

Category: Suturing needle holder, reusable

Marina Medical by Marina Medical Instruments, 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: Marina Medical Instruments, Inc.

Sources (1)

FDA UDI 1e3faea1-2e06-457b-aa07-dfef52da4f06 36 fields · synced May 31, 2026