FDA.reportPublic FDA data

Marina Medical

Primary DI
00840306823459
Brand
Marina Medical
Company
MARINA MEDICAL INSTRUMENTS, INC.
Model
200-340
Catalog number
200-340
Device description
Bane-Hartmann Bone Rongeur : 19cm/7.5in
Published
2025-02-14
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
HTXRONGEUR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTXRongeurOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840306823459PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840306823459008403068234598403068234590840306823459

GMDN Terms#

Term, Definition table
TermDefinition
Craniofacial rongeur, reusableA hand-held manual surgical instrument with sharp, scoop-shaped jaws designed for cutting tough tissues (cartilage, sinew) or bone, through a cutting/biting action, during surgery involving the cranium and/or face (e.g., craniotomy, ethmoidectomy, mastoidectomy, rhinoplasty); it is not dedicated to dental surgery. It is typically made of metal and designed to withstand the forces required to bite over tough/hard tissue. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length19Centimeter

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
00198506091216ELMED INCORPORATEDELMED INCORPORATEDHTX2026-06-03
00846338005719ForcepsELLIQUENCE, LLCHTX2026-06-02
00846338005726ForcepsELLIQUENCE, LLCHTX2026-06-02
00846338005757ForcepsELLIQUENCE, LLCHTX2026-06-02
00846338005764ForcepsELLIQUENCE, LLCHTX2026-06-02
00846338005771ForcepsELLIQUENCE, LLCHTX2026-06-02
00846338005788ForcepsELLIQUENCE, LLCHTX2026-06-02
00810189451490Surgical DesignSurgical Design, Inc.HTX2026-05-29
09348811172174INKAThe Trustee for KAISER FAMILY TRUSTHTX2025-11-21
G586NS5235002SPFB10Novo SurgicalNOVO SURGICAL, INC.HTX2025-02-06
G586NS20266610Novo SurgicalNOVO SURGICAL, INC.HTX2024-02-22
G586NS20286510Novo SurgicalNOVO SURGICAL, INC.HTX2024-02-22
G586NS20286810Novo SurgicalNOVO SURGICAL, INC.HTX2024-02-22
G586NS34214310Novo SurgicalNOVO SURGICAL, INC.HTX2024-02-22
G45333CC96MM900PEAK MEDPeak Medical Distribution Inc.HTX2023-03-07
07640178988750JULIET ® INSTRUMENTATIONSpineArt SAHTX2019-01-15
07640178988767JULIET ® INSTRUMENTATIONSpineArt SAHTX2019-01-15
07640185340602SCARLET AL-T INSTRUMENTATIONSpineArt SAHTX2018-12-10
07640185340787SCARLET AL-T INSTRUMENTATIONSpineArt SAHTX2018-12-10
07640185340794SCARLET AL-T INSTRUMENTATIONSpineArt SAHTX2018-12-10
07640185340800SCARLET AL-T INSTRUMENTATIONSpineArt SAHTX2018-12-10
07640185340817SCARLET AL-T INSTRUMENTATIONSpineArt SAHTX2018-12-10
07640185340824SCARLET AL-T INSTRUMENTATIONSpineArt SAHTX2018-12-10
10381780194521Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHTX2018-04-02
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10381780194545Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHTX2018-04-02
10381780194552Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHTX2018-04-02
10381780194569Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHTX2018-04-02
10381780194576Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHTX2018-04-02
10381780194583Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHTX2018-04-02