PD-CTTU-600504

GUDID 04589551362943

NAKANISHI INC.

Luminal device flushing tubing set, reusable
Primary Device ID04589551362943
NIH Device Record Key62cb8046-63e9-4da1-835f-a90b58aef88d
Commercial Distribution StatusIn Commercial Distribution
Brand NamePD-CTTU-600504
Version Model NumberPD-CTTU-600504
Company DUNS690710546
Company NameNAKANISHI INC.
Device Count4
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104589551354573 [Primary]
GS104589551362943 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWEINSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-05-18
Device Publish Date2022-05-10

Devices Manufactured by NAKANISHI INC.

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04589551384006 - Bur Stopper Puller2024-11-21
04560264502963 - PTL Nozzle2024-11-11
04560264502970 - EZ-M4 Adaptor2024-11-11
04589551392063 - EZ SPRAY2024-11-11
04589551391950 - M2052024-10-24
04560264578586 - FX204 M42024-10-24
04589551389391 - Surgic Pro2 OPT2024-10-23

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