FDA.report

Marina Medical

Primary DI
00840306829987
Brand
Marina Medical
Company
MARINA MEDICAL INSTRUMENTS, INC.
Model
337-244
Catalog number
337-244
Device description
Hemorrhage Occluder Only Pin, sterile (single)
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

Related Records

Contact Domains

Product Codes

CodeName
HOYShield, eye, ophthalmic (including sunlamp protective eyewear and post-mydriatic eyewear)
HXKHOLDER, NEEDLE; ORTHOPEDIC

Product Code Classifications

CodeDeviceSpecialtyClass
HOYShield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)Ophthalmic1
HXKHolder, Needle; OrthopedicOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840306829987PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840306829987008403068299878403068299870840306829987

GMDN Terms

TermDefinition
Suturing needle holder, reusableA hand-held manual surgical instrument designed to grasp a suture needle when pushing/pulling the needle and attached suture through tissue during suturing. It is typically made of metal and has short serrated jaws at the distal end to provide better grip of the needle. It is available in a wide variety of sizes and designs, such as: 1) a self-retaining, scissors-like design with ring handles at the proximal end; 2) a tweezers-like design with bowed, hinged handles that are operated by squeezing them together; and 3) a heavy-duty pincer-like design. Some types may utilize inserts made of hard materials (e.g., carbide) and include scissor blades. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

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

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00840306837333Marina Medical99-76099-7602026-02-18
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00840306837357Marina Medical050-472SCE050-472SCE2026-02-18
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00840306837289Marina Medical33727-1733727-172025-09-03
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00840306837227Marina Medical1570-BR21570-BR22025-08-08
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00840306837258Marina Medical1570-BR61570-BR62025-08-08
00840306837265Marina Medical1570-BR101570-BR102025-08-08
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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

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