FDA.reportPublic FDA data

PD-CTTU-600504

Primary DI
04589551362943
Brand
PD-CTTU-600504
Company
NAKANISHI INC.
Model
PD-CTTU-600504
Published
2022-05-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
04589551354573PrimaryGS10
04589551362943Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04589551354573045895513545734589551354573
04589551362943045895513629434589551362943

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
690710546
Device count
4
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
04560264510920Ti-Max XX572020-06-05
04560264510937Ti-Max XX35L2020-06-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613327652741N/ASTRYKER CORPORATIONHWE2026-03-25
07613327652758N/ASTRYKER CORPORATIONHWE2026-03-25
07613327652789N/ASTRYKER CORPORATIONHWE2026-03-25
07640187462302Power Tool TL Attachment 2.5mmBonebridge AGHWE2025-10-17
07613327649161T2, PANGEAStryker GmbHHWE2025-09-25
07613327566000T2 ALPHAStryker GmbHHWE2024-03-01
07613327566055T2 ALPHAStryker GmbHHWE2024-03-01
07613327566079T2 ALPHAStryker GmbHHWE2024-03-01
07613327538939Prep PlusSTRYKER CORPORATIONHWE2023-01-04
07613327539332Mill PlusSTRYKER CORPORATIONHWE2023-01-04
07613327539349Mill PlusSTRYKER CORPORATIONHWE2023-01-04
07613327539448Mill PlusSTRYKER CORPORATIONHWE2023-01-04
07613327542134Bone Mill PlusSTRYKER CORPORATIONHWE2022-12-22
07613327467765EZoutSTRYKER CORPORATIONHWE2021-06-17
07613327467864PrecisionSTRYKER CORPORATIONHWE2021-06-17
07613327467819NASTRYKER CORPORATIONHWE2021-06-15
07613327467826NASTRYKER CORPORATIONHWE2021-06-15
07613327467833NASTRYKER CORPORATIONHWE2021-06-15
07613327467840NASTRYKER CORPORATIONHWE2021-06-15
07613327467857NASTRYKER CORPORATIONHWE2021-06-15
08800038040359Brasseler EZXIMEDICOM CO., LTD.HWE2020-06-17
08800038040366Brasseler EZXIMEDICOM CO., LTD.HWE2020-06-17
08800038040373Brasseler EZXIMEDICOM CO., LTD.HWE2020-06-17
08800038040380Brasseler EZXIMEDICOM CO., LTD.HWE2020-06-17
08800038040397Brasseler EZXIMEDICOM CO., LTD.HWE2020-06-17
08800038040403Brasseler EZXIMEDICOM CO., LTD.HWE2020-06-17
08800038040410Brasseler EZXIMEDICOM CO., LTD.HWE2020-06-17
08800038040427Brasseler EZXIMEDICOM CO., LTD.HWE2020-06-17
08800038040441Brasseler EZXIMEDICOM CO., LTD.HWE2020-06-17
08800038040458Brasseler EZXIMEDICOM CO., LTD.HWE2020-06-17