Marina Medical

FDA UDI

Class I (US FDA UDI)

by Marina Medical Instruments, Inc.

Identity

Trade Name: Marina Medical FDA UDI
Generic Name: Skin marking guide, reusable FDA UDI
Device Name: Barron Areola Marker, 40/44/48/52mm FDA UDI
Model / Reference: 201-046 FDA UDI
Description: Barron Areola Marker, 40/44/48/52mm FDA UDI

Identifiers

Catalog Number: 201-046 FDA UDI
Primary DI / UDI-DI: 00840306805677 FDA UDI
FDA Product Code: FZZ FDA UDI
GMDN Term: Skin marking guide, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4660 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: Skin marking guide, 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 Skin marking guide, reusable.

ASSI — ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORP. · Class I
Snowden-Pencer — STERIS CORPORATION · Class I
Avalign — AVALIGN TECHNOLOGIES, Inc. · Class I
FREEMAN AREOLA MARKER SET — SONTEC INSTRUMENTS, INC. · Class I
RZ Medizintechnik GmbH — RZ-Medizintechnik GmbH · Class I
Avalign — AVALIGN TECHNOLOGIES, Inc. · Class I
BOSS Instruments — Boss Instruments, Ltd. · Class I
ASSI — ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORP. · 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 9a74cce6-d314-462b-b750-712abe5e4ab9 35 fields · synced May 31, 2026