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
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840306837333Marina Medical99-76099-7602026-02-18
00840306837340Marina Medical050-335SCE050-335SCE2026-02-18
00840306837357Marina Medical050-472SCE050-472SCE2026-02-18
00840306837272Marina Medical33725-1733725-172025-09-03
00840306837289Marina Medical33727-1733727-172025-09-03
00840306837203Marina Medical1575-CCS16301575-CCS16302025-08-08
00840306837210Marina Medical1575-CCS18301575-CCS18302025-08-08
00840306837227Marina Medical1570-BR21570-BR22025-08-08
00840306837234Marina Medical1570-BR31570-BR32025-08-08
00840306837241Marina Medical1570-BR51570-BR52025-08-08
00840306837258Marina Medical1570-BR61570-BR62025-08-08
00840306837265Marina Medical1570-BR101570-BR102025-08-08
00840306837180Marina Medical110-346110-3472025-07-02
00840306837197Marina Medical110-347110-3472025-07-02
00840306837173Marina Medical050-964050-9642025-06-04
00840306805882Marina MedicalR642.07R642.072025-04-04
00840306812026Marina Medical180-140180-1402025-03-12
00840306830938Marina Medical20-017020-01702025-03-12
00840306830945Marina Medical20-017420-01742025-03-12
00840306836466Marina Medical200-262200-2622025-03-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506087691ELMED INCORPORATEDELMED INCORPORATEDFFQ2026-01-16
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00190776409180MillenniumAvalign Technologies, Inc.FFQ2025-08-22
00190776409265MillenniumAvalign Technologies, Inc.FFQ2025-08-22
00190776409272MillenniumAvalign Technologies, Inc.FFQ2025-08-22
00190776408299MillenniumAvalign Technologies, Inc.FFQ2025-08-07
00198506084201ELMED INCORPORATEDELMED INCORPORATEDFFQ2025-07-17
00190776402983MillenniumAvalign Technologies, Inc.FFQ2025-06-30
00190776399627MillenniumAvalign Technologies, Inc.FFQ2025-06-02
00190776399634MillenniumAvalign Technologies, Inc.FFQ2025-06-02
00190776399764MillenniumAvalign Technologies, Inc.FFQ2025-06-02
04049047074663GimmiGimmi GmbHFFQ2025-05-20
04049047074670GimmiGimmi GmbHFFQ2025-05-20
04049047316848GimmiGimmi GmbHFFQ2025-05-20
00190776393717MillenniumAvalign Technologies, Inc.FFQ2025-05-06
00190776393724MillenniumAvalign Technologies, Inc.FFQ2025-05-06
00190776393731MillenniumAvalign Technologies, Inc.FFQ2025-05-06
00190776393748MillenniumAvalign Technologies, Inc.FFQ2025-05-06
00190776393755MillenniumAvalign Technologies, Inc.FFQ2025-05-06
00198506082610ELMED INCORPORATEDELMED INCORPORATEDFFQ2025-05-06
00190776393182MillenniumAvalign Technologies, Inc.FFQ2025-05-05
00198506082375ELMED INCORPORATEDELMED INCORPORATEDFFQ2025-04-21
00198506081248ELMED INCORPORATEDELMED INCORPORATEDFFQ2025-03-14
00198506075537ELMED INCORPORATEDELMED INCORPORATEDFFQ2025-02-21
00198506074066ELMED INCORPORATEDELMED INCORPORATEDFFQ2025-01-03
00198506073816ELMED INCORPORATEDELMED INCORPORATEDFFQ2024-12-19
00190776389918MillenniumAvalign Technologies, Inc.FFQ2024-11-18
00190776389130MillenniumAvalign Technologies, Inc.FFQ2024-11-14
00198506073243ELMED INCORPORATEDELMED INCORPORATEDFFQ2024-11-11