FDA.reportPublic FDA data

Marina Medical

Primary DI
00840306823619
Brand
Marina Medical
Company
MARINA MEDICAL INSTRUMENTS, INC.
Model
200-800
Catalog number
200-800
Device description
"Arkansas Novaculite Black Translucent Sharpener (1400 grit US) - 6"" X 2"" X 1/2"""
Published
2025-01-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
EMIFILE, BONE, SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMIFile, Bone, SurgicalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840306823619PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840306823619008403068236198403068236190840306823619

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone pin sharpenerA hand-held manual surgical instrument used to alter the tip of a bioabsorbable bone pin, e.g., to shorten it, prior to insertion into the patient. It is typically designed with a handle at the proximal end and a long, sturdy, shaft that terminates in a sharpener with a cutting blade similar in design to a pencil sharpener. It is typically made of high-grade stainless steel and/or synthetic material and is used by the surgeon or assistive surgical staff inside the sterile field of the operating room (OR). This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length6Inch

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(954)924-4418enrico@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
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
00840306835551Marina Medical800-400-05800-400-052024-10-11
00840306834479Marina Medical521-055521-0552024-09-19
00840306834516Marina Medical522-055522-0552024-09-19
00840306834523Marina Medical522-360522-3602024-09-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00348783010053Premier FilePREMIER DENTAL PRODUCTS COMPANYEMI2026-04-27
00840018672642Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEMI2026-02-11
00840018663589Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEMI2026-02-04
00840018665514Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEMI2026-02-04
00840018662476Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEMI2026-01-29
00840018662858Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEMI2026-01-29
00840018663220Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEMI2026-01-29
00194613115968MSI Precision Specialty InstrumentsMed Saver, Inc.EMI2025-08-01
00190776405229MillenniumAvalign Technologies, Inc.EMI2025-07-14
00889813066874Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEMI2025-02-12
00889813066881Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEMI2025-02-12
00840306823626Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.EMI2025-01-17
00813677025135PDT, Inc.PDT, INC.EMI2024-08-12
06974456210761CICADAFoshan Cicada Dental Instrument Co., Ltd.EMI2024-08-10
86974456210767CICADAFoshan Cicada Dental Instrument Co., Ltd.EMI2024-08-10
00813677024558PDT, Inc.PDT, INC.EMI2024-07-03
00813677024497PDT, Inc.PDT, INC.EMI2024-06-27
00190776388911AvalignAvalign Technologies, Inc.EMI2024-05-15
00842517105638Karl SchumacherKarl Schumacher Dental, LLCEMI2024-03-18
00842517105645Karl SchumacherKarl Schumacher Dental, LLCEMI2024-03-18
00888515225336BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.EMI2024-02-28
00888515225374BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.EMI2024-02-28
00888515225497BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.EMI2024-02-28
08800075612892OSUNG MNDOSUNG MND Co., Ltd.EMI2024-02-27
08800075612908OSUNG MNDOSUNG MND Co., Ltd.EMI2024-02-27
08800075612878OSUNG MNDOSUNG MND Co., Ltd.EMI2024-02-19
D955BFS3201Paul BandittTerlain Enterprises, Inc.EMI2023-12-11
D955BFX1101Paul BandittTerlain Enterprises, Inc.EMI2023-12-11
D955BFX12C1Paul BandittTerlain Enterprises, Inc.EMI2023-12-11
D955BFX2301Paul BandittTerlain Enterprises, Inc.EMI2023-12-11