FDA.reportPublic FDA data

Kamiyama

Primary DI
04580036673189
Brand
Kamiyama
Company
TAKAYAMA INSTRUMENTS INC.
Model
KT-702
Catalog number
KT-702
Device description
Micro Rongeur K-Bayonet, 200mm (90mm W.L.), Slightly Curved Tip
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
04580036673189PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04580036673189045800366731894580036673189

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
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
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
04250418753395Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGZX2025-03-27
04250418753401Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGZX2025-03-27
04250418753418Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGZX2025-03-27
04250418753425Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGZX2025-03-27
04250418753432Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGZX2025-03-27
04250418753449Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGZX2025-03-27
G586NS5235002SPFB10Novo SurgicalNOVO SURGICAL, INC.HTX2025-02-06
04250418753296Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGZX2025-01-02
04250418753302Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGZX2025-01-02
04250418753319Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGZX2025-01-02
04250418753326Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGZX2025-01-02
04250418753333Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGZX2025-01-02
04250418753258Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGZX2024-12-18
04250418753265Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGZX2024-12-18
04250418753272Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGZX2024-12-18
04250418753289Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGZX2024-12-18
04250418753166Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGZX2024-12-17
04250418753173Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGZX2024-12-17