FDA.reportPublic FDA data

Marina Medical

Primary DI
00840306802386
Brand
Marina Medical
Company
MARINA MEDICAL INSTRUMENTS, INC.
Model
08-0165
Catalog number
08-0165
Device description
Accessory, Sheath, Spatula Tip, Rotating, Stop-Cock
Published
2025-10-24
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
MDMINSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MDMInstrument, Manual, Surgical, General UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840306802386PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840306802386008403068023868403068023860840306802386

GMDN Terms#

Term, Definition table
TermDefinition
Endoscope sheath, reusableA component of a rigid or flexible endoscope assembly designed as a tube through which an endoscope (e.g., hysteroscope) and endoscopic elements are introduced and assembled to create a complete operative endoscopic unit; it is also designed to function as a protective barrier to isolate the endoscope from patient contact and prevent contamination of the endoscope controls during a procedure. It typically contains ports to enable the insertion of instruments (through the endoscope or through independent working channels), insufflation ports, valves and connectors. It is made of plastic and metal materials. 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
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
00190776411534MillenniumAvalign Technologies, Inc.MDM2026-08-07
00190776423575MillenniumAvalign Technologies, Inc.MDM2026-08-07
00190776424435MillenniumAvalign Technologies, Inc.MDM2026-08-07
B382SD923286060Surgical DirectSurgical Direct, Inc.MDM2026-08-07
00190776422806MillenniumAvalign Technologies, Inc.MDM2026-08-03
00198506092350ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-29
00198506093197ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-29
00198506093586ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-29
00198506090561ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-28
00198506092589ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-28
00198506092671ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-28
00198506092695ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-28
00198506092701ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-28
00198506092718ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-28
00198506092725ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-28
00198506093012ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-28
00198506093029ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-28
00198506093111ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-28
00198506093166ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-28
00198506093203ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-28
00198506093296ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-28
00198506093364ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-28
00198506093371ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-28
00198506093425ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-28
00198506093432ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-28
00198506093463ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-28
00198506092039ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-27
00198506092046ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-27
00198506092398ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-27
00198506092404ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-27