Marina Medical

FDA UDI

Class I (US FDA UDI)

by Marina Medical Instruments, Inc.

Identity

Trade Name: Marina Medical FDA UDI
Generic Name: Scalpel, single-use FDA UDI
Device Name: Scalpel Handle # 3, for Blade sizes # 10-18, 13cm FDA UDI
Model / Reference: 040-070 FDA UDI
Description: Scalpel Handle # 3, for Blade sizes # 10-18, 13cm FDA UDI

Identifiers

Catalog Number: 040-070 FDA UDI
Primary DI / UDI-DI: 00840306800139 FDA UDI
FDA Product Code: GDZ FDA UDI
GMDN Term: Scalpel, single-use 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: Scalpel, single-use

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

Similar devices

Also classified as Scalpel, single-use.

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DeRoyal — DEROYAL INDUSTRIES, INC. · Class I
comknife® — Beijing Bohai Kangyuan Medical Devices Co., Ltd. · Class I
Bard-Parker ® Disposable Scalpels — Aspen Surgical Products, Inc. · Class I
Sharpoint — Surgical Specialties México, S. de R.L. de C.V. · Class I
comknife® — Beijing Bohai Kangyuan Medical Devices Co., Ltd. · Class I
Stylus — Surgical Specialties México, S. de R.L. de C.V. · 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

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Manufacturer

Manufacturer: Marina Medical Instruments, Inc.

Sources (1)

FDA UDI d516bf8c-2ab0-4d26-92b9-d593cc61234a 36 fields · synced May 31, 2026