FDA.reportPublic FDA data

Marina Medical

Primary DI
00840306823190
Brand
Marina Medical
Company
MARINA MEDICAL INSTRUMENTS, INC.
Model
200-128
Catalog number
200-128
Device description
Sheehan Osteotome, 8mm, 16cm
Published
2024-04-18
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
GFIOSTEOTOME, MANUAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GFIOsteotome, ManualGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840306823190PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840306823190008403068231908403068231900840306823190

GMDN Terms#

Term, Definition table
TermDefinition
Plastic surgery osteotomeA surgical, chisel-like, instrument designed to cut and/or shape small bones and/or cartilage during plastic surgery. It is hand-held by the surgeon who will typically use a surgical mallet or hammer to manually impart an impacting force to the proximal end of the instrument. The distal end (the cutting or shaping edge) is sharp, often flat, but can be curved (concave) in design, and is typically bevelled on either side with sloping curves. This device will be made of high-grade stainless steel and be used for plastic surgery procedures (e.g., to shape nasal cartilage). This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length16Centimeter

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
G149TBSB7860TBS BASICSACME ENTERPRISE.GFI2026-05-22
G149TBSB7870TBS BASICSACME ENTERPRISE.GFI2026-05-22
G149TBSB7880TBS BASICSACME ENTERPRISE.GFI2026-05-22
10889981443764SpecialsSeaspine Orthopedics CorporationGFI2026-03-03
D9281051992HF0SINUS INSTRUMENT #2 HF D/EW.H. Holden, Inc.GFI2026-02-19
10889981441340SpecialsSeaspine Orthopedics CorporationGFI2026-01-30
10889981441357SpecialsSeaspine Orthopedics CorporationGFI2026-01-30
10889981441364SpecialsSeaspine Orthopedics CorporationGFI2026-01-30
10889981441371SpecialsSeaspine Orthopedics CorporationGFI2026-01-30
03662663220873Breckenridge ACDF SystemHighridge Medical, LLCGFI2026-01-13
03662663220880Breckenridge ACDF SystemHighridge Medical, LLCGFI2026-01-13
03662663220897Breckenridge ACDF SystemHighridge Medical, LLCGFI2026-01-13
10889981440787SpecialsSeaspine Orthopedics CorporationGFI2026-01-07
03662663156783SOLITAIRE CERVICAL SPACER SYSTEMHighridge Medical, LLCGFI2025-12-29
03662663156790SOLITAIRE CERVICAL SPACER SYSTEMHighridge Medical, LLCGFI2025-12-29
03662663156806SOLITAIRE CERVICAL SPACER SYSTEMHighridge Medical, LLCGFI2025-12-29
03662663156813SOLITAIRE CERVICAL SPACER SYSTEMHighridge Medical, LLCGFI2025-12-29
03662663156820SOLITAIRE CERVICAL SPACER SYSTEMHighridge Medical, LLCGFI2025-12-29
03662663156837SOLITAIRE CERVICAL SPACER SYSTEMHighridge Medical, LLCGFI2025-12-29
00757770703708Bausch + LombBausch & Lomb IncorporatedGFI2025-12-12
00757770703715Bausch + LombBausch & Lomb IncorporatedGFI2025-12-12
00757770447046Bausch + LombBausch & Lomb IncorporatedGFI2025-12-11
00810207783312Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDGFI2025-11-24
00810207783329Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDGFI2025-11-24
00810207783336Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDGFI2025-11-24
00810207783343Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDGFI2025-11-24
00810207783350Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDGFI2025-11-24
00810207783367Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDGFI2025-11-24
00810207783374Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDGFI2025-11-24
00810207783381Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDGFI2025-11-24