FDA.reportPublic FDA data

Kamiyama

Primary DI
04580036673196
Brand
Kamiyama
Company
TAKAYAMA INSTRUMENTS INC.
Model
K-500
Catalog number
K-500
Device description
Micro Dilator Straight, 185mm, 45degree 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
MDMInstrument, Manual, Surgical, General Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MDMInstrument, Manual, Surgical, General UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04580036673196PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04580036673196045800366731964580036673196

GMDN Terms#

Term, Definition table
TermDefinition
Fascial tissue dilator, reusableA surgical instrument used for stretching or enlarging the fascial tissue covering a cavity, tract, or opening typically prior to the introduction of a catheter during an invasive diagnostic or surgical procedure (e.g., femoral artery catheterization). It is a rod-like device with a long, slender, hollow or solid body and a rounded nose at its distal end, that is available in a variety of sizes and made of metal (e.g., stainless steel). It is typically used for the dilatation of fascial tissue around peripheral vasculature, puncture sites, and various ducts. 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
00198506091353ELMED INCORPORATEDELMED INCORPORATEDMDM2026-06-09
00198506091360ELMED INCORPORATEDELMED INCORPORATEDMDM2026-06-09
00198506091377ELMED INCORPORATEDELMED INCORPORATEDMDM2026-06-09
00198506091384ELMED INCORPORATEDELMED INCORPORATEDMDM2026-06-09
00198506091391ELMED INCORPORATEDELMED INCORPORATEDMDM2026-06-09
00198506091407ELMED INCORPORATEDELMED INCORPORATEDMDM2026-06-09
00198506091209ELMED INCORPORATEDELMED INCORPORATEDMDM2026-06-03
00810130456406Medco ManufacturingMedco Manufacturing LLCMDM2026-06-02
00846338007126Endiscope and accessoriesELLIQUENCE, LLCMDM2026-06-02
00846338005429DilatorELLIQUENCE, LLCMDM2026-06-01
06932503510219Pulmonary Hydro-Slide GuidewireMicro-Tech (Nanjing) Co., Ltd.MDM2026-05-29
06932503510226Pulmonary Hydro-Slide GuidewireMicro-Tech (Nanjing) Co., Ltd.MDM2026-05-29
B356KE392100American MedicalsAmerican MedicalsMDM2026-05-29
B356KE396100American MedicalsAmerican MedicalsMDM2026-05-29
08800042700102Artisential Fenestrated ForcepsLIVSMEDMDM2026-04-29
08800042700140Artisential Maryland DissectorLIVSMEDMDM2026-04-29
08800042700256Artisential Fenestrated ForcepsLIVSMEDMDM2026-04-29
08800042700270Artisential Fenestrated ForcepsLIVSMEDMDM2026-04-29
08800042700287Artisential Fenestrated ForcepsLIVSMEDMDM2026-04-29
08800042700300Artisential Maryland DissectorLIVSMEDMDM2026-04-29
08800042700317Artisential Maryland DissectorLIVSMEDMDM2026-04-29
08800042700324Artisential Maryland DissectorLIVSMEDMDM2026-04-29
08800042700386Artisential Needle HolderLIVSMEDMDM2026-04-29
08800042700393Artisential Needle HolderLIVSMEDMDM2026-04-29
08800042700416Artisential Needle HolderLIVSMEDMDM2026-04-29
08800042700423Artisential Needle HolderLIVSMEDMDM2026-04-29
08800042700843Artisential Precise Needle HolderLIVSMEDMDM2026-04-29
08800042700850Artisential Precise Needle HolderLIVSMEDMDM2026-04-29
08800042700874Artisential Precise Needle HolderLIVSMEDMDM2026-04-29
08800042700881Artisential Precise Needle HolderLIVSMEDMDM2026-04-29