Marina Medical

FDA UDI

Class I (US FDA UDI)

by Marina Medical Instruments, Inc.

Identity

Trade Name: Marina Medical FDA UDI
Generic Name: Manual goniometer FDA UDI
Device Name: Titanium Nasal Goniometer (40 - 160°) FDA UDI
Model / Reference: 580-000 FDA UDI
Description: Titanium Nasal Goniometer (40 - 160°) FDA UDI

Identifiers

Catalog Number: 580-000 FDA UDI
Primary DI / UDI-DI: 00840306809484 FDA UDI
FDA Product Code: MDM FDA UDI
GMDN Term: Manual goniometer 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: Manual goniometer

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

Similar devices

Also classified as Manual goniometer.

INSTRUMENT — Howmedica Osteonics Corp. · Class I
Ambler Surgical — Ambler Surgical, LLC · Class I
DEPUY — DEPUY ORTHOPAEDICS, INC. · Class I
GONIOMETER INTL STD 12.5IN — AliMed, LLC · Class I
gSource — GSOURCE, LLC. · Class I
TC-100 — Smith & Nephew, Inc. · Class II
TC-100 — Smith & Nephew, Inc. · Class II
Medline — MEDLINE INDUSTRIES, INC. · Class I

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Marina Medical Instruments, Inc.

Sources (1)

FDA UDI d63ebe82-6075-4395-8102-e07347d18424 35 fields · synced Jun 6, 2026