FDA.reportPublic FDA data

Marina Medical

Primary DI
00840306824500
Brand
Marina Medical
Company
MARINA MEDICAL INSTRUMENTS, INC.
Model
220-328
Catalog number
220-328
Device description
Walther Female Dilator-Catheters 13cm, 28Fr
Published
2024-04-29
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
HDQDILATOR, CERVICAL, FIXED SIZE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HDQDilator, Cervical, Fixed SizeObstetrics/Gynecology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840306824500PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840306824500008403068245008403068245000840306824500

GMDN Terms#

Term, Definition table
TermDefinition
Vascular dilator, reusableA hand-held surgical instrument designed for insertion into a blood vessel (the vasculature) to unblock, enlarge or measure the internal diameter of the vessel during a surgical intervention. It is a rod-like device with a long, slender, body that terminates with a bulbous, cylindrical distal tip of various shapes and sizes. Commonly known as a vessel dilator or vascular probe, it is available in a variety of sizes (diameters and lengths) and flexibilities. It is typically made of metal or plastic materials. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length13Centimeter

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
00190776407469MillenniumAvalign Technologies, Inc.HDQ2026-07-31
00198506093180ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-07-28
00198506093241ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-07-28
00198506093357ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-07-28
00860011927686Monarch Medical ProductsBioteque Taiwan Ltd.HDQ2026-07-24
04719894436517LTL MedicalBioteque Taiwan Ltd.HDQ2026-07-24
00198506093692ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-07-22
00198506093708ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-07-22
00198506093715ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-07-22
00198506093722ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-07-22
00198506092466ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-07-17
00198506092473ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-07-17
00198506092480ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-07-17
00198506092497ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-07-17
00198506092503ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-07-17
00198506092510ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-07-17
00198506092527ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-07-17
00198506092534ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-07-17
00198506092541ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-07-17
00198506092558ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-07-17
00198506092565ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-07-17
00198506092572ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-07-17
00348783011265Premier DilatorPREMIER DENTAL PRODUCTS COMPANYHDQ2026-06-08
00348783011272Premier DilatorPREMIER DENTAL PRODUCTS COMPANYHDQ2026-06-08
00348783011289Premier DilatorPREMIER DENTAL PRODUCTS COMPANYHDQ2026-06-08
00348783011296Premier DilatorPREMIER DENTAL PRODUCTS COMPANYHDQ2026-06-08
00348783011302Premier DilatorPREMIER DENTAL PRODUCTS COMPANYHDQ2026-06-08
00348783011319Premier DilatorPREMIER DENTAL PRODUCTS COMPANYHDQ2026-06-08
04719894432434BiotequeBioteque Taiwan Ltd.HDQ2024-04-08
04719894432441BiotequeBioteque Taiwan Ltd.HDQ2024-04-08