FDA.reportPublic FDA data

Marina Medical

Primary DI
00840306833021
Brand
Marina Medical
Company
MARINA MEDICAL INSTRUMENTS, INC.
Model
BRK2.50
Catalog number
BRK2.50
Device description
#3 Ring Pessary, Incontinence Knob, No Support
Published
2024-12-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
HHWPESSARY, VAGINAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HHWPessary, VaginalObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840306833021PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840306833021008403068330218403068330210840306833021

GMDN Terms#

Term, Definition table
TermDefinition
Pelvic-organ-supporting pessaryA device made of rubber or soft plastics designed for insertion into the vagina to hold the uterus, bladder and/or rectum in place and help prevent prolapse (falling or sliding of the organ from its normal position into the pelvic cavity), either as a permanent or temporary treatment; it is not dedicated to bladder-only support. It is available in a variety of shapes (e.g., rings, stems) and sizes; it may be fitted for each woman individually. This is a reusable device after appropriate cleaning.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(954)924-4419enrico@marinamedical.com
+1(954)924-4418enrico@marinamedical.com

Regulatory Flags#

DUNS number
011442279
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840306817755Marina Medical110-691LS110-691LS2024-03-20
00840306837388Marina Medical200-281200-2812026-05-11
00840306837395Marina Medical200-280200-2802026-05-11
00840306811586Marina Medical110-671L110-671L2024-01-30
00840306811654Marina Medical110-689L110-689L2024-01-30
00840306811661Marina Medical110-800110-8002024-01-30
00840306837364Marina Medical050-182CER050-182CER2026-04-15
00840306837371Marina Medical050-701CER050-701CER2026-04-15
00840306837272Marina Medical33725-1733725-172025-09-03
00840306837289Marina Medical33727-1733727-172025-09-03
00840306837333Marina Medical99-76099-7602026-02-18
00840306837340Marina Medical050-335SCE050-335SCE2026-02-18
00840306837357Marina Medical050-472SCE050-472SCE2026-02-18
00840306824579Marina Medical222-222222-2222024-05-01
00840306835919Marina Medical800-935800-9352024-12-10
00840306835940Marina Medical800-943800-9432024-12-11
00840306835933Marina Medical800-941800-9412024-10-22
00840306835551Marina Medical800-400-05800-400-052024-10-11
00840306834479Marina Medical521-055521-0552024-09-19
00840306834516Marina Medical522-055522-0552024-09-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850073946008EvaCarePERSONAL MEDICAL CORP.HHW2026-07-14
00850073946015EvaCarePERSONAL MEDICAL CORP.HHW2026-07-14
00850073946022EvaCarePERSONAL MEDICAL CORP.HHW2026-07-14
00850073946039EvaCarePERSONAL MEDICAL CORP.HHW2026-07-14
00850073946046EvaCarePERSONAL MEDICAL CORP.HHW2026-07-14
00850073946053EvaCarePERSONAL MEDICAL CORP.HHW2026-07-14
00850073946060EvaCarePERSONAL MEDICAL CORP.HHW2026-07-14
00850073946077EvaCarePERSONAL MEDICAL CORP.HHW2026-07-14
00850073946084EvaCarePERSONAL MEDICAL CORP.HHW2026-07-14
00850073946091EvaCarePERSONAL MEDICAL CORP.HHW2026-07-14
00850073946107EvaCarePERSONAL MEDICAL CORP.HHW2026-07-14
00850073946114EvaCarePERSONAL MEDICAL CORP.HHW2026-07-14
00850073946121EvaCarePERSONAL MEDICAL CORP.HHW2026-07-14
00850073946138EvaCarePERSONAL MEDICAL CORP.HHW2026-07-14
00850073946145EvaCarePERSONAL MEDICAL CORP.HHW2026-07-14
00850073946152EvaCarePERSONAL MEDICAL CORP.HHW2026-07-14
00850073946169EvaCarePERSONAL MEDICAL CORP.HHW2026-07-14
00850073946176EvaCarePERSONAL MEDICAL CORP.HHW2026-07-14
00850073946183EvaCarePERSONAL MEDICAL CORP.HHW2026-07-14
00850073946190EvaCarePERSONAL MEDICAL CORP.HHW2026-07-14
00850073946206EvaCarePERSONAL MEDICAL CORP.HHW2026-07-14
00850073946213EvaCarePERSONAL MEDICAL CORP.HHW2026-07-14
00850073946220EvaCarePERSONAL MEDICAL CORP.HHW2026-07-14
00850073946237EvaCarePERSONAL MEDICAL CORP.HHW2026-07-14
00850073946244EvaCarePERSONAL MEDICAL CORP.HHW2026-07-14
00850073946251EvaCarePERSONAL MEDICAL CORP.HHW2026-07-14
00850073946268EvaCarePERSONAL MEDICAL CORP.HHW2026-07-14
00850073946275EvaCarePERSONAL MEDICAL CORP.HHW2026-07-14
00850073946282EvaCarePERSONAL MEDICAL CORP.HHW2026-07-14
00850073946299EvaCarePERSONAL MEDICAL CORP.HHW2026-07-14