FDA.reportPublic FDA data

PD-CTTU-150252

Primary DI
04589551354610
Brand
PD-CTTU-150252
Company
NAKANISHI INC.
Model
PD-CTTU-150252
Published
2022-05-10
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
HWEINSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/AttachmentGeneral, Plastic Surgery1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K202120000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202120000P300 AttachmentNakanishi, Inc.2021-10-22HBE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04589551354610PrimaryGS10
04589551362950Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04589551354610045895513546104589551354610
04589551362950045895513629504589551362950

GMDN Terms#

Term, Definition table
TermDefinition
Luminal device flushing tubing set, reusableA collection of devices which includes connection tubing intended to be fitted to a luminal device (e.g., catheter, endoscope channel, ophthalmic handpiece) to assist flushing the device lumen during a medical/surgical procedure, and/or to assist the washing, disinfection and/or sterilization of the lumen. In addition to tubing, the set includes connectors/valves to allow appropriate fluids (e.g., sterilant, disinfectant) and gases to flow through the device lumen. It may be used in conjunction with a syringe, device washer/disinfector, and/or water tap. This is a reusable device.

Regulatory Flags#

DUNS number
690710546
Device count
2
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04589551386758VA-SG-TIP HOLDERVA-SG-TIP HOLDER2026-04-08
04589551395088Multi Pad2Multi Pad22026-06-02
04589551366583Sterile Cutting ToolUBS-RD70C2-082026-05-22
04589551366590Sterile Cutting ToolUBS-RD70C2-072026-05-22
04589551366606Sterile Cutting ToolUBS-RD50C2-082026-05-22
04589551366613Sterile Cutting ToolUBS-RD50C2-072026-05-22
04560264564213iProphy mobileiProphy mobile Motor2020-06-18
04589551392940WrenchWrench2026-04-27
04589551389186VS4-LED-HPSCVS4-LED-HPSC2026-04-23
04589551389216FC-86FC-862026-04-23
04589551390960VarioSurg 4 (120V)VarioSurg 4 (120V)2026-04-23
04589551390977VarioSurg 4 w/o FC (120V)VarioSurg 4 w/o FC (120V)2026-04-23
04589551393398FC-78FC-782026-04-23
04589551389001CR-30CR-302026-04-20
04589551391462M-RE2M-RE22026-04-20
04589551391479M-ST1M-ST12026-04-20
04589551391486M-OC1RM-OC1R2026-04-20
04589551391493M-OC1LM-OC1L2026-04-20
04589551393589SG12SG122026-04-20
04560264510913Ti-Max XX57L2020-06-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842078125724CarilaginatorEXTREMITY MEDICAL, LLCHWE2026-06-09
00842078125748CarilaginatorEXTREMITY MEDICAL, LLCHWE2026-06-09
00842078130261CarilaginatorEXTREMITY MEDICAL, LLCHWE2026-06-09
00842078130315CarilaginatorEXTREMITY MEDICAL, LLCHWE2026-06-09
00842078130452CarilaginatorEXTREMITY MEDICAL, LLCHWE2026-06-09
00842078130490CarilaginatorEXTREMITY MEDICAL, LLCHWE2026-06-09
00842078130537CarilaginatorEXTREMITY MEDICAL, LLCHWE2026-06-09
00842078134054CarilaginatorEXTREMITY MEDICAL, LLCHWE2026-06-09
00842078134061CarilaginatorEXTREMITY MEDICAL, LLCHWE2026-06-09
00842078134078CarilaginatorEXTREMITY MEDICAL, LLCHWE2026-06-09
00842078134085CarilaginatorEXTREMITY MEDICAL, LLCHWE2026-06-09
00842078134092CarilaginatorEXTREMITY MEDICAL, LLCHWE2026-06-09
00842078134108CarilaginatorEXTREMITY MEDICAL, LLCHWE2026-06-09
00842078134115CarilaginatorEXTREMITY MEDICAL, LLCHWE2026-06-09
00850078396303PFT Adapter, SYK, Virata, 85 in-lb (228-TXRX-006)Eca Medical InstrumentsHWE2026-06-05
00850078396310PFT Adapter, SYK, Mariner, 105 in-lb (228-TXRX-007)Eca Medical InstrumentsHWE2026-06-05
10705034647807TRIALTISMedos International SàrlHWE2026-06-03
10705034647814TRIALTISMedos International SàrlHWE2026-06-03
10705034647821TRIALTISMedos International SàrlHWE2026-06-03
10705034647838TRIALTISMedos International SàrlHWE2026-06-03
10705034648118TRIALTISMedos International SàrlHWE2026-06-03
00810111227292K-WireTreace Medical Concepts, Inc.HWE2026-06-02
07613327648331PANGEAStryker GmbHHWE2026-06-02
07613327648362PANGEAStryker GmbHHWE2026-06-02
07613327652703N/ASTRYKER CORPORATIONHWE2026-04-15
07613327652710PROstepSTRYKER CORPORATIONHWE2026-04-13
07613327652727N/ASTRYKER CORPORATIONHWE2026-04-13
07613327652734N/ASTRYKER CORPORATIONHWE2026-04-13
07613327652741N/ASTRYKER CORPORATIONHWE2026-03-25
07613327652758N/ASTRYKER CORPORATIONHWE2026-03-25