FDA.reportPublic FDA data

Marina Medical

Primary DI
00840306806452
Brand
Marina Medical
Company
MARINA MEDICAL INSTRUMENTS, INC.
Model
BRK2.00
Catalog number
BRK2.00
Device description
#1 Ring Pessary, Incontinence Knob, No Support
Published
2024-01-30
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
LRYPUNCH, SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HHWPessary, VaginalObstetrics/Gynecology2
LRYPunch, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840306806452PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840306806452008403068064528403068064520840306806452

GMDN Terms#

Term, Definition table
TermDefinition
Open-surgery biopsy forceps, single-useA hand-held manual surgical instrument designed to obtain soft-tissue biopsy specimens from an open surgical wound or from within/near a large natural orifice (e.g., vagina, rectum) for histopathological examination; it is not intended for endoscopic or catheterized access. It is a metallic forceps-like instrument with a distal mechanism designed to bite/punch the biopsy sample and hold it for extraction when the handles are squeezed together. It is not designed for cutting bone (i.e., not a rongeur). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length25.5Centimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(954)924-4418enrico@marinamedical.com
+1(954)924-4419enrico@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
00840306837401Marina Medical190-224190-2242026-07-21
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B8035903620ORTHOMEDORTHO-MED, INC.LRY2026-10-14
B8035903630ORTHOMEDORTHO-MED, INC.LRY2026-10-14
00348783016055PremierBioteque Taiwan Ltd.HHW2026-09-02
00348783016109PremierBioteque Taiwan Ltd.HHW2026-09-02
00348783016116PremierBioteque Taiwan Ltd.HHW2026-09-02
00348783016215PremierBioteque Taiwan Ltd.HHW2026-09-02
04719894432083BiotequeBioteque Taiwan Ltd.HHW2026-09-02
04719894432090BiotequeBioteque Taiwan Ltd.HHW2026-09-02
04719894432106BiotequeBioteque Taiwan Ltd.HHW2026-09-02
04719894432137BiotequeBioteque Taiwan Ltd.HHW2026-09-02
04719894432144BiotequeBioteque Taiwan Ltd.HHW2026-09-02
04719894432151BiotequeBioteque Taiwan Ltd.HHW2026-09-02
04719894432168BiotequeBioteque Taiwan Ltd.HHW2026-09-02
04719894432175BiotequeBioteque Taiwan Ltd.HHW2026-09-02
00348783016062PremierBioteque Taiwan Ltd.HHW2026-09-01
00348783016079PremierBioteque Taiwan Ltd.HHW2026-09-01
00348783016086PremierBioteque Taiwan Ltd.HHW2026-09-01
00348783016093PremierBioteque Taiwan Ltd.HHW2026-09-01
00348783016208PremierBioteque Taiwan Ltd.HHW2026-09-01
00348783016048PremierBioteque Taiwan Ltd.HHW2026-09-01
04719894432113BiotequeBioteque Taiwan Ltd.HHW2026-09-01
04719894432120BiotequeBioteque Taiwan Ltd.HHW2026-09-01
00810142350334Bioteque America, Inc.Bioteque America, Inc.HHW2025-06-02
00810142350587Bioteque America, Inc.Bioteque America, Inc.HHW2025-05-29
00810142350594Bioteque America, Inc.Bioteque America, Inc.HHW2025-05-29
00810142350600Bioteque America, Inc.Bioteque America, Inc.HHW2025-05-29
00810142350617Bioteque America, Inc.Bioteque America, Inc.HHW2025-05-29
00810142350624Bioteque America, Inc.Bioteque America, Inc.HHW2025-05-29
00810142350631Bioteque America, Inc.Bioteque America, Inc.HHW2025-05-29
00810142350648Bioteque America, Inc.Bioteque America, Inc.HHW2025-05-29