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Marina Medical

FDA UDI

Class I (US FDA UDI)

by Marina Medical Instruments, Inc.

Identity

Trade Name
Marina Medical FDA UDI
Generic Name
Vascular graft tunneller FDA UDI
Device Name
25cm Tunneler, Fully Curved with 8mm Bullet Tip FDA UDI
Model / Reference
MM-TUN8C025 FDA UDI
Description
25cm Tunneler, Fully Curved with 8mm Bullet Tip FDA UDI

Identifiers

Catalog Number
MM-TUN8C025 FDA UDI
Primary DI / UDI-DI
00840306810459 FDA UDI
FDA Product Code
DWS FDA UDI
GMDN Term
Vascular graft tunneller FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
870.4500 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI
MRI Safety
MR Safe FDA UDI

Category: Vascular graft tunneller

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

Similar devices

Also classified as Vascular graft tunneller.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Marina Medical Instruments, Inc.

Sources (1)

  • FDA UDI a2802e57-b97a-4b55-babe-2c72928a8913 35 fields · synced May 30, 2026