FDA.reportPublic FDA data

Marina Medical

Primary DI
00840306823763
Brand
Marina Medical
Company
MARINA MEDICAL INSTRUMENTS, INC.
Model
201-050
Catalog number
201-050
Device description
Freeman Areola Marker, 50mm
Published
2024-04-25
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
FZZMARKER, SKIN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZZMarker, SkinGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840306823763PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840306823763008403068237638403068237630840306823763

GMDN Terms#

Term, Definition table
TermDefinition
Skin marking guide, reusableA device intended to be used as a guide to create an accurate mark on the skin surface with a drawing skin marker (e.g., a skin marking pen), or by itself after having been dipped in a marking agent (e.g., ink), typically to outline a surgical incision site or for dermatology applications. It is typically shaped specifically for its intended application. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length50Millimeter

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
G42520103680My MedicalMy Medical Store LLCFZZ2026-02-26
G42520104020My MedicalMy Medical Store LLCFZZ2026-02-26
26931918101047AllesetGRI Medical & Electronic Technology Co., Ltd.FZZ2026-02-09
26931918108411AllesetGRI Medical & Electronic Technology Co., Ltd.FZZ2026-02-09
26931918152353AllesetGRI Medical & Electronic Technology Co., Ltd.FZZ2026-02-09
26931918161324AllesetGRI Medical & Electronic Technology Co., Ltd.FZZ2026-02-09
26931918172931AllesetGRI Medical & Electronic Technology Co., Ltd.FZZ2026-02-09
07540277010041RMAC SurgicalRMAC Surgical, IncFZZ2026-01-06
00860012465019FungalBlueToeFX IncFZZ2025-12-03
00194613019075MSI Precision Specialty InstrumentsMed Saver, Inc.FZZ2025-08-01
00194613020842MSI Precision Specialty InstrumentsMed Saver, Inc.FZZ2025-08-01
00194613022754MSI Precision Specialty InstrumentsMed Saver, Inc.FZZ2025-08-01
00194613043643MSI Precision Specialty InstrumentsMed Saver, Inc.FZZ2025-08-01
00194613046187MSI Precision Specialty InstrumentsMed Saver, Inc.FZZ2025-08-01
00194613057039MSI Precision Specialty InstrumentsMed Saver, Inc.FZZ2025-08-01
00194613088286MSI Precision Specialty InstrumentsMed Saver, Inc.FZZ2025-08-01
00194613094058MSI Precision Specialty InstrumentsMed Saver, Inc.FZZ2025-08-01
00194613094065MSI Precision Specialty InstrumentsMed Saver, Inc.FZZ2025-08-01
00194613094072MSI Precision Specialty InstrumentsMed Saver, Inc.FZZ2025-08-01
00194613107116MSI Precision Specialty InstrumentsMed Saver, Inc.FZZ2025-08-01
00194613108496MSI Precision Specialty InstrumentsMed Saver, Inc.FZZ2025-08-01
00194613121020MSI Precision Specialty InstrumentsMed Saver, Inc.FZZ2025-08-01
00194613123260MSI Precision Specialty InstrumentsMed Saver, Inc.FZZ2025-08-01
00194613123277MSI Precision Specialty InstrumentsMed Saver, Inc.FZZ2025-08-01
00194613123291MSI Precision Specialty InstrumentsMed Saver, Inc.FZZ2025-08-01
G2231523360Medetz Surgical InstrumentsMedetz Surgical Instruments LLCFZZ2025-06-30
10714646001129Sample: Opti-TattBionix, LLCFZZ2025-06-20
40080196771852MEDLINEMEDLINE INDUSTRIES, INC.FZZ2025-06-12
40884389025940MEDLINEMEDLINE INDUSTRIES, INC.FZZ2025-06-12
40884389711799MEDLINEMEDLINE INDUSTRIES, INC.FZZ2025-06-12