FDA.reportPublic FDA data

Kamiyama

Primary DI
04580036675930
Brand
Kamiyama
Company
TAKAYAMA INSTRUMENTS INC.
Model
MT-15-C15
Catalog number
MT-15-C15
Device description
Micro Rongeur, Double link, Curved 15 deg neck, 1.5mm Blades width
Published
2025-06-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GZXInstrument, Microsurgical
HTXRongeur

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GZXInstrument, MicrosurgicalNeurology1
HTXRongeurOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04580036675930PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04580036675930045800366759304580036675930

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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
707948014
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04580036672748KamiyamaK-101-1K-101-12025-06-26
04580036672755KamiyamaK-101-2K-101-22025-06-26
04580036672762KamiyamaK-102-1K-102-12025-06-26
04580036672779KamiyamaK-102-2K-102-22025-06-26
04580036672786KamiyamaK-103K-1032025-06-26
04580036672793KamiyamaK-104K-1042025-06-26
04580036672809KamiyamaK-110-1K-110-12025-06-26
04580036672816KamiyamaK-110-2K-110-22025-06-26
04580036672823KamiyamaK-111-1K-111-12025-06-26
04580036672830KamiyamaK-111-2K-111-22025-06-26
04580036672847KamiyamaK-3030K-30302025-06-26
04580036672854KamiyamaK-3010K-30102025-06-26
04580036672861KamiyamaK-203K-2032025-06-26
04580036672878KamiyamaK-1030K-10302025-06-26
04580036672885KamiyamaK-2030K-20302025-06-26
04580036672892KamiyamaK-2010K-20102025-06-26
04580036672908KamiyamaKTP-120KTP-1202025-06-26
04580036672915KamiyamaKTP-230KTP-2302025-06-26
04580036672922KamiyamaKTP-340KTP-3402025-06-26
04580036672939KamiyamaKTP-1520KTP-15202025-06-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00846159039672SCANLAN® InstrumentSCANLAN INTERNATIONAL INCGZX2026-05-27
00846159039689SCANLAN® InstrumentSCANLAN INTERNATIONAL INCGZX2026-05-27
00846159039696SCANLAN® ScissorsSCANLAN INTERNATIONAL INCGZX2026-05-27
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
G223150101200Medetz Surgical InstrumentsMedetz Surgical Instruments LLCGZX2023-06-15
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
10381780165491Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHTX2018-03-27
10381780167259Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGZX2018-03-27
10381780167273Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGZX2018-03-27
10381780183686Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHTX2018-03-27
10381780183693Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHTX2018-03-27
10381780183723Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHTX2018-03-27
10381780183730Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHTX2018-03-27
10381780185505Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGZX2018-03-27
10381780185536Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGZX2018-03-27
10381780185543Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGZX2018-03-27
10381780185550Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGZX2018-03-27