FDA.reportPublic FDA data

Marina Medical

Primary DI
00840306834967
Brand
Marina Medical
Company
MARINA MEDICAL INSTRUMENTS, INC.
Model
604-604
Catalog number
604-604
Device description
MACINTOSH laryngoscope blade fig 4, integrated fiber optic, green system, reusable, working length 5 3/8” (136 mm)
Published
2025-01-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
FSXLight, surgical, connector

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSXLight, Surgical, ConnectorGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840306834967PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840306834967008403068349678403068349670840306834967

GMDN Terms#

Term, Definition table
TermDefinition
Light source adaptorA small connecting device designed to permit the connection of the devices that together deliver light to a work field from a light source. This device is used to connect together products of dissimilar manufacture and dimensions, e.g., a fibreoptic light cable of one manufacture to the light source of another. It may also be used at the instrument end. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00840306834523Marina Medical522-360522-3602024-09-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840306834950Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.FSX2025-01-21
00840306825613Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.FSX2025-01-17
00840306834943Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.FSX2025-01-16
00840306834974Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.FSX2025-01-16
00840306834981Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.FSX2025-01-16
10886705029198NAMedos International SàrlFSX2022-02-09
10886705029204NAMedos International SàrlFSX2022-02-09
10886705029211NAMedos International SàrlFSX2022-02-09
10886705029228NAMedos International SàrlFSX2022-02-09
10886705029235NAMedos International SàrlFSX2022-02-09
10886705029242NAMedos International SàrlFSX2022-02-09
10886705029259NAMedos International SàrlFSX2022-02-09