Marina Medical

FDA UDI

Class I (US FDA UDI)

by Marina Medical Instruments, Inc.

Identity

Trade Name: Marina Medical FDA UDI
Generic Name: Assistive dressing/undressing hook/stick FDA UDI
Device Name: K-Needles (box of 10) FDA UDI
Model / Reference: 200-042 FDA UDI
Description: K-Needles (box of 10) FDA UDI

Identifiers

Catalog Number: 200-042 FDA UDI
Primary DI / UDI-DI: 00840306823121 FDA UDI
FDA Product Code: HCF FDA UDI
GMDN Term: Assistive dressing/undressing hook/stick 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

Category: Assistive dressing/undressing hook/stick

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

Similar devices

Also classified as Assistive dressing/undressing hook/stick.

DeRoyal — DEROYAL INDUSTRIES, INC. · Class I
Millennium — AVALIGN TECHNOLOGIES, Inc. · Class I
Vive — VIVE HEALTH LLC · Class I
DeRoyal — DEROYAL INDUSTRIES, INC. · Class I
MSI Precision Specialty Instruments — Med Saver, Inc. · Class I
DeRoyal — DEROYAL INDUSTRIES, INC. · Class I
DeRoyal — DEROYAL INDUSTRIES, INC. · Class I
DeRoyal — DEROYAL 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 6a1dcde3-440d-475e-9b8b-6b5fb88741fb 35 fields · synced May 31, 2026