FDA.reportPublic FDA data

Marina Medical

Primary DI
00840306824524
Brand
Marina Medical
Company
MARINA MEDICAL INSTRUMENTS, INC.
Model
220-332
Catalog number
220-332
Device description
Walther Female Dilator-Catheters 13cm, 32Fr
Published
2024-04-29
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
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
00840306824524PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840306824524008403068245248403068245240840306824524

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
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
00190776417789MillenniumAvalign Technologies, Inc.HDQ2026-03-11
00198506088230ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-01-27
00198506088247ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-01-27
00198506088254ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-01-27
00198506088261ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-01-27
00198506087981ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-01-22
00198506087998ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-01-22
00198506088001ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-01-22
00198506088018ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-01-22
00198506088025ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-01-22
00198506088032ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-01-22
00198506088049ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-01-22
04262494463143N/ADoppkon GmbH & Co. KGHDQ2025-12-04
04262494462986N/ADoppkon GmbH & Co. KGHDQ2025-12-01
04262494462993N/ADoppkon GmbH & Co. KGHDQ2025-12-01
04262494463006N/ADoppkon GmbH & Co. KGHDQ2025-12-01
04262494463013N/ADoppkon GmbH & Co. KGHDQ2025-12-01
04262494463020N/ADoppkon GmbH & Co. KGHDQ2025-12-01
00190776411671MillenniumAvalign Technologies, Inc.HDQ2025-09-25
00190776411688MillenniumAvalign Technologies, Inc.HDQ2025-09-25
00190776411695MillenniumAvalign Technologies, Inc.HDQ2025-09-25
00190776411732MillenniumAvalign Technologies, Inc.HDQ2025-09-25
00190776411749MillenniumAvalign Technologies, Inc.HDQ2025-09-25
00190776411756MillenniumAvalign Technologies, Inc.HDQ2025-09-25
00190776411459MillenniumAvalign Technologies, Inc.HDQ2025-09-24
00190776411466MillenniumAvalign Technologies, Inc.HDQ2025-09-24
00190776411596MillenniumAvalign Technologies, Inc.HDQ2025-09-24
00190776411602MillenniumAvalign Technologies, Inc.HDQ2025-09-24
00190776411435MillenniumAvalign Technologies, Inc.HDQ2025-09-22
00190776411442MillenniumAvalign Technologies, Inc.HDQ2025-09-22