FDA.reportPublic FDA data

Marina Medical

Primary DI
00840306835551
Brand
Marina Medical
Company
MARINA MEDICAL INSTRUMENTS, INC.
Model
800-400-05
Catalog number
800-400-05
Device description
5cc cap to fat injection gun
Published
2024-10-11
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
MDMINSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MDMInstrument, Manual, Surgical, General UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840306835551PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840306835551008403068355518403068355510840306835551

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic surgical instrument handle, manualA hand-held manual device designed to hold and operate a compatible ophthalmic surgical instrument tip (typically scissors, forceps). It is typically in the form of a conventional handle with a connector that secures the inserted tip, and has a manually-operated internal actuating piston that operates the inserted tip (e.g., opens and closes blades). It is typically used for surgery in the anterior or the posterior segment to cut, grasp, and manipulate eye tissue; it is not a handle for a corneal trephine. 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

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
00840306834479Marina Medical521-055521-0552024-09-19
00840306834516Marina Medical522-055522-0552024-09-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00888867574489Arthrex®ARTHREX, INC.MDM2026-09-18
00888867574496Arthrex®ARTHREX, INC.MDM2026-09-18
00888867574502Arthrex®ARTHREX, INC.MDM2026-09-18
00888867574519Arthrex®ARTHREX, INC.MDM2026-09-18
00888867574526Arthrex®ARTHREX, INC.MDM2026-09-18
00888867574533Arthrex®ARTHREX, INC.MDM2026-09-18
10888277688896MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-18
10888277688902MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-18
10888277688919MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-18
10888277688926MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-18
10888277688933MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-18
10888277688940MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-18
10888277688957MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-18
10888277688964MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-18
10888277689121MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-18
10080196321384MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-14
10888277688995MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-14
10888277689008MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-14
10888277689015MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-14
10888277689022MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-14
10888277689039MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-14
10888277689046MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-14
10888277689053MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-14
10888277689060MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-14
10888277689077MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-14
10888277689084MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-14
10888277689091MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-14
10888277689107MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-14
10888277689114MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-14
10080196320417MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-09