FDA.reportPublic FDA data

Marina Medical

Primary DI
00840306824104
Brand
Marina Medical
Company
MARINA MEDICAL INSTRUMENTS, INC.
Model
210-003
Catalog number
210-003
Device description
Hirschmann Anoscope, Large, 2.2cm ID
Published
2024-04-26
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
FFQSPECULUM, RECTAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FFQSpeculum, RectalGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840306824104PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840306824104008403068241048403068241040840306824104

GMDN Terms#

Term, Definition table
TermDefinition
Optical anoscope, reusableAn endoscope with a rigid inserted portion intended for the visual examination and treatment of the anus and rectum. It is inserted into the body through the anus during anoscopy. The inserted portion is short in length, though longer than a sphincteroscope, and large in diameter, and an obturator is typically inserted into its lumen to assist the insertion. The anatomical images are illuminated by a built-in or external light source and can be viewed by the user through relayed lens optics or direct vision. This device is typically used to examine/diagnose patients suffering pain in the rectum/anus, haemorrhoids, or anal fissures. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length2.2Centimeter

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
B382SD917665100Surgical DirectSurgical Direct, Inc.FFQ2026-10-20
B382SD917665110Surgical DirectSurgical Direct, Inc.FFQ2026-10-20
B382SD917665120Surgical DirectSurgical Direct, Inc.FFQ2026-10-20
B382SD917665700Surgical DirectSurgical Direct, Inc.FFQ2026-10-20
B382SD917665920Surgical DirectSurgical Direct, Inc.FFQ2026-10-20
B382SD917665930Surgical DirectSurgical Direct, Inc.FFQ2026-10-20
00190776433352MillenniumAvalign Technologies, Inc.FFQ2026-10-05
00190776433369MillenniumAvalign Technologies, Inc.FFQ2026-10-05
00190776433376MillenniumAvalign Technologies, Inc.FFQ2026-10-05
00190776433383MillenniumAvalign Technologies, Inc.FFQ2026-10-05
00190776433390MillenniumAvalign Technologies, Inc.FFQ2026-10-05
00190776433406MillenniumAvalign Technologies, Inc.FFQ2026-10-05
00190776433413MillenniumAvalign Technologies, Inc.FFQ2026-10-05
00190776433420MillenniumAvalign Technologies, Inc.FFQ2026-10-05
00190776433437MillenniumAvalign Technologies, Inc.FFQ2026-10-05
00190776433444MillenniumAvalign Technologies, Inc.FFQ2026-10-05
00190776433451MillenniumAvalign Technologies, Inc.FFQ2026-10-05
00190776433468MillenniumAvalign Technologies, Inc.FFQ2026-10-05
00190776433475MillenniumAvalign Technologies, Inc.FFQ2026-10-05
00190776433482MillenniumAvalign Technologies, Inc.FFQ2026-10-05
00190776433499MillenniumAvalign Technologies, Inc.FFQ2026-10-05
00190776433505MillenniumAvalign Technologies, Inc.FFQ2026-10-05
G141554100200Carnegie Surgical LLCCarnegie Surgical LLCFFQ2026-09-30
00190776432362MillenniumAvalign Technologies, Inc.FFQ2026-09-24
00860015748508Thermora AnoscopeOMEC Medical (NV) Inc.FFQ2026-07-31
00190776422189MillenniumAvalign Technologies, Inc.FFQ2026-07-28
00850048720619Speculum KitsSpecialty Health Products, LLCFFQ2026-07-23
00850048720626Speculum KitsSpecialty Health Products, LLCFFQ2026-07-23
00850048720633Speculum KitsSpecialty Health Products, LLCFFQ2026-07-23
00850048720640Speculum KitsSpecialty Health Products, LLCFFQ2026-07-23