FDA.reportPublic FDA data

Marina Medical

Primary DI
00840306831188
Brand
Marina Medical
Company
MARINA MEDICAL INSTRUMENTS, INC.
Model
380-202
Catalog number
380-202
Device description
Pederson Speculum, Smoke Tube, Laser, 11.5cm x 2.5cm
Published
2024-07-19
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
FTYTAPE, MEASURING, RULERS AND CALIPERS
HDFSPECULUM, VAGINAL, METAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FTYTape, Measuring, Rulers And CalipersGeneral, Plastic Surgery1
HDFSpeculum, Vaginal, MetalObstetrics/Gynecology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840306831188PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840306831188008403068311888403068311880840306831188

GMDN Terms#

Term, Definition table
TermDefinition
Medical ruler, reusableA small straight-edged strip intended to be used to measure the length of internal or external anatomy, devices or instruments in a clinical setting. It is marked in units of length (i.e., inches, millimetres and/or centimetres), and may be an independent bendable strip applied to measured surfaces or a strip incorporated into a form convenient for measuring specific devices (e.g., screws). It is not dedicated to wound measurements. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length11.5Centimeter
Length762Centimeter

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
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
00190776428150MillenniumAvalign Technologies, Inc.HDF2026-08-27
00190776428181MillenniumAvalign Technologies, Inc.HDF2026-08-27
00190776428198MillenniumAvalign Technologies, Inc.HDF2026-08-27
00190776428242MillenniumAvalign Technologies, Inc.HDF2026-08-27
00190776419622MillenniumAvalign Technologies, Inc.HDF2026-08-23
00724995314217V. MuellerSteris CorporationFTY2026-08-21
B382SD915039080Surgical DirectSurgical Direct, Inc.HDF2026-08-21
B382SD915039140Surgical DirectSurgical Direct, Inc.HDF2026-08-21
B382SD915039150Surgical DirectSurgical Direct, Inc.HDF2026-08-21
00190776426750MillenniumAvalign Technologies, Inc.FTY2026-08-19
00190776426439MillenniumAvalign Technologies, Inc.HDF2026-08-18
00190776426446MillenniumAvalign Technologies, Inc.HDF2026-08-18
00198506093944ELMED INCORPORATEDELMED INCORPORATEDHDF2026-08-18
00198506094088ELMED INCORPORATEDELMED INCORPORATEDHDF2026-08-18
00198506094095ELMED INCORPORATEDELMED INCORPORATEDHDF2026-08-18
00198506094101ELMED INCORPORATEDELMED INCORPORATEDHDF2026-08-18
00198506094118ELMED INCORPORATEDELMED INCORPORATEDHDF2026-08-18
00850088713534PRINCETONPrinceton Medical Group, Inc.HDF2026-08-14
00190776408817MillenniumAvalign Technologies, Inc.HDF2026-08-03
00190776422639MillenniumAvalign Technologies, Inc.HDF2026-08-03
00198506093845ELMED INCORPORATEDELMED INCORPORATEDHDF2026-07-29
00198506093852ELMEDELMED INCORPORATEDHDF2026-07-29
00198506093142ELMED INCORPORATEDELMED INCORPORATEDHDF2026-07-28
00198506093265ELMED INCORPORATEDELMED INCORPORATEDHDF2026-07-28
00198506093272ELMED INCORPORATEDELMED INCORPORATEDHDF2026-07-28
00198506093418ELMED INCORPORATEDELMED INCORPORATEDHDF2026-07-28
00810143906042SURGIPROSSurgipros, LLCFTY2026-07-28
00810212935539SURGIPROSSurgipros, LLCFTY2026-07-28
B382SD915038100Surgical DirectSurgical Direct, Inc.HDF2026-07-28
B382SD915038110Surgical DirectSurgical Direct, Inc.HDF2026-07-28