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Marina Medical

FDA UDI

Class II (US FDA UDI)

by Marina Medical Instruments, Inc.

Identity

Trade Name
Marina Medical FDA UDI
Generic Name
Pelvic-organ-supporting pessary FDA UDI
Device Name
#5 Donut Pessary FDA UDI
Model / Reference
BD3.25 FDA UDI
Description
#5 Donut Pessary FDA UDI

Identifiers

Catalog Number
BD3.25 FDA UDI
Primary DI / UDI-DI
00840306833960 FDA UDI
FDA Product Code
HHW FDA UDI
GMDN Term
Pelvic-organ-supporting pessary FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
884.3575 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

Category: Pelvic-organ-supporting pessary

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

Similar devices

Also classified as Pelvic-organ-supporting pessary.

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 82053fe9-2846-47c6-9adf-64f07b733044 35 fields · synced Jun 8, 2026