FDA.reportPublic FDA data

Marina Medical

Primary DI
00840306836602
Brand
Marina Medical
Company
MARINA MEDICAL INSTRUMENTS, INC.
Model
350-512
Catalog number
350-512
Device description
Device, Endoscopy, Wireless Digital Camera
Published
2025-02-14
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
FWDCAMERA, TELEVISION, MICROSURGICAL, WITHOUT AUDIO

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FWDCamera, Television, Microsurgical, Without AudioGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840306836602PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840306836602008403068366028403068366020840306836602

GMDN Terms#

Term, Definition table
TermDefinition
Endoscope video cameraAn electro-optical device (e.g., a CCD) designed to be attached, either directly or with an adaptor, to a flexible or rigid endoscope to allow real-time viewing of the internal anatomy during an endoscopic surgical procedure and to obtain moving-picture documentation of endoscopic findings and procedures. The device is designed for transducing visual images as a sequence of electronic data following a pre-established standard; the images are usually displayed sequentially on the screen of a monitor as a video image. The device may include audio recording capabilities.

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
Lot or batch
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
B366U1VI360R04Procam HD CMOS IIEclerisFWD2026-05-27
B366U1VI3605PROCAM 4K USBEclerisFWD2026-05-19
B366U1HC130G21Procam 4KEclerisFWD2025-12-22
B366U1VI3701Procam 4KEclerisFWD2025-12-22
B366AIO100BRX1PROCAM PACKEclerisFWD2025-08-22
B366AIO100SRX1PROCAM PACK SEclerisFWD2025-08-22
B366FE1023RX1PROCAM FLEXEclerisFWD2025-08-22
B366U1VI360100BRX1PROCAM PACKEclerisFWD2025-08-22
B366U1VI360100SRX1PROCAM PACK SEclerisFWD2025-08-22
B366U1VI3604RX1PROCAM HD USBEclerisFWD2025-08-22
B366U1HC120G21R06Procam HD CMOS II CONSOLEEclerisFWD2025-07-30
B366U1VI3601R04Procam HD CMOS IIEclerisFWD2025-07-30
B366U1VI3603RX2Procam HD IIEclerisFWD2025-07-30
00840306836374Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.FWD2025-01-27
B366U1VI3603RX1Procam HD IIEclerisFWD2024-09-25
00840306831058Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.FWD2024-07-19
08436041580270OptomicOPTOMIC ESPAÑA SAFWD2024-07-17
08436041580294OptomicOPTOMIC ESPAÑA SAFWD2024-07-17
B366U1VI360Procam HD CMOS IIEclerisFWD2023-09-19
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M6337059243100JEDMEDJEDMED INSTRUMENT COMPANYFWD2023-02-07