Handpiece Stand

GUDID 04589551390182

NAKANISHI INC.

Surgical power tool system control unit, line-powered
Primary Device ID04589551390182
NIH Device Record Key7e2c4b41-700b-4489-817d-8e825bb6c1a4
Commercial Distribution StatusIn Commercial Distribution
Brand NameHandpiece Stand
Version Model NumberHandpiece Stand
Company DUNS690710546
Company NameNAKANISHI INC.
Device Count1
DM Exempttrue
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
GS104589551390182 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EBWController, foot, handpiece and cord

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04589551390182]

Moist Heat or Steam Sterilization


[04589551390182]

Moist Heat or Steam Sterilization


[04589551390182]

Moist Heat or Steam Sterilization


[04589551390182]

Moist Heat or Steam Sterilization


[04589551390182]

Moist Heat or Steam Sterilization


[04589551390182]

Moist Heat or Steam Sterilization


[04589551390182]

Moist Heat or Steam Sterilization


[04589551390182]

Moist Heat or Steam Sterilization


[04589551390182]

Moist Heat or Steam Sterilization


[04589551390182]

Moist Heat or Steam Sterilization


[04589551390182]

Moist Heat or Steam Sterilization


[04589551390182]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-11-25
Device Publish Date2024-11-15

Devices Manufactured by NAKANISHI INC.

04560264575158 - Nozzle Holder2024-11-25
04560264575165 - Nozzle Holder2024-11-25
04560264575172 - Internal Spray Nozzle2024-11-25
04560264575189 - Cleaning Wire2024-11-25
04560264575271 - Tube Holder2024-11-25
04560264576506 - Protection Plug2024-11-25
04560264576513 - Coolant Solution Hanger Post2024-11-25
04589551392421 - Tube Holder2024-11-25

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