FDA.reportPublic FDA data

Marina Medical

Primary DI
00840306830068
Brand
Marina Medical
Company
MARINA MEDICAL INSTRUMENTS, INC.
Model
338-301
Catalog number
338-301
Device description
Collar and Screw for Jarco Cannula
Published
2024-08-06
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
LKFCannula, manipulator/injector, uterine

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LKFCannula, Manipulator/Injector, UterineObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840306830068PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840306830068008403068300688403068300680840306830068

GMDN Terms#

Term, Definition table
TermDefinition
Uterine elevatorA hand-held surgical instrument used to lift and manipulate the structure of the uterus to facilitate examination and surgery on this organ and/or the surrounding organs/tissue during a surgical intervention. It is typically a single-ended device with a blunted blade or hook with no cutting edges that can be of various shapes and a handle at the proximal end. It is usually made of high-grade stainless steel. This is a reusable device.

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
20859500005008FemVueFEMASYS INC.LKF2026-01-06
30859500005005FemVueFEMASYS INC.LKF2026-01-06
00198506017919ELMED INCORPORATEDELMED INCORPORATEDLKF2025-08-11
10860010540937Rejoni Ribbed CatheterRejoni, Inc.LKF2025-02-18
00840306835360Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.LKF2025-02-12
00840306835377Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.LKF2025-02-12
00840306835384Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.LKF2025-02-12
00840306835391Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.LKF2025-02-12
00840306835407Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.LKF2025-02-12
00840306835544Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.LKF2025-02-12
00840306835865Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.LKF2025-02-12
00840306835872Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.LKF2025-02-12
00840306835889Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.LKF2025-02-12
00840306835896Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.LKF2025-02-12
00840306835902Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.LKF2025-02-12
00840306836022Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.LKF2025-02-12
00840306836046Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.LKF2025-02-12
00840306836053Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.LKF2025-02-12
00198506074264ELMED INCORPORATEDELMED INCORPORATEDLKF2025-01-15
00198506017858ELMED INCORPORATEDELMED INCORPORATEDLKF2025-01-10
04719894432977Bioteque Taiwan Ltd.Bioteque Taiwan Ltd.LKF2024-12-06
04719894432984Bioteque Taiwan Ltd.Bioteque Taiwan Ltd.LKF2024-12-06
04719894432991Bioteque Taiwan Ltd.Bioteque Taiwan Ltd.LKF2024-12-06
04719894433004Bioteque Taiwan Ltd.Bioteque Taiwan Ltd.LKF2024-12-06
00198506017827ELMED INCORPORATEDELMED INCORPORATEDLKF2024-11-14
00859500005097FemChec FEMASYS INC.LKF2024-09-16
00840306830044Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.LKF2024-08-06
00840306830051Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.LKF2024-08-06
00840306830075Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.LKF2024-08-06
00840306830099Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.LKF2024-08-06