Marina Medical

FDA UDI

Class I (US FDA UDI)

by Marina Medical Instruments, Inc.

Identity

Trade Name: Marina Medical FDA UDI
Generic Name: Endodontic broach, serrated, reusable FDA UDI
Device Name: Myoma Drill, 5mm working length FDA UDI
Model / Reference: 332-519 FDA UDI
Description: Myoma Drill, 5mm working length FDA UDI

Identifiers

Catalog Number: 332-519 FDA UDI
Primary DI / UDI-DI: 00840306807589 FDA UDI
FDA Product Code: GAD FDA UDI
GMDN Term: Endodontic broach, serrated, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4800 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

Category: Endodontic broach, serrated, 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 7a3b9536-0f7f-440e-8606-8fc5cc40aa34 35 fields · synced May 30, 2026