Bone Cut Kit

GUDID 04560264563025

NAKANISHI INC.

Dental ultrasonic surgical system handpiece tip
Primary Device ID04560264563025
NIH Device Record Keyc1db940e-102b-4e5a-9be2-4c4956a4c4f5
Commercial Distribution StatusIn Commercial Distribution
Brand NameBone Cut Kit
Version Model NumberBone Cut Kit
Company DUNS690710546
Company NameNAKANISHI INC.
Device Count1
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 Batchtrue
Serial Numberfalse
Manufacturing Datefalse
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
GS104560264563025 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DZIDRILL, BONE, POWERED

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04560264563025]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-16

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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