X-SG93

GUDID 04560264557116

NAKANISHI INC.

Dental power tool system handpiece, line-powered
Primary Device ID04560264557116
NIH Device Record Keyc1adc12b-ec79-4dbe-b9f0-a8f32d2c1ee9
Commercial Distribution StatusIn Commercial Distribution
Brand NameX-SG93
Version Model NumberX-SG93
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 Batchfalse
Serial Numbertrue
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
GS104560264557116 [Direct Marking]
GS104589551382453 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KMWHANDPIECE, ROTARY BONE CUTTING

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04560264557116]

Moist Heat or Steam Sterilization


[04560264557116]

Moist Heat or Steam Sterilization


[04560264557116]

Moist Heat or Steam Sterilization


[04560264557116]

Moist Heat or Steam Sterilization


[04560264557116]

Moist Heat or Steam Sterilization


[04560264557116]

Moist Heat or Steam Sterilization


[04560264557116]

Moist Heat or Steam Sterilization


[04560264557116]

Moist Heat or Steam Sterilization


[04560264557116]

Moist Heat or Steam Sterilization


[04560264557116]

Moist Heat or Steam Sterilization


[04560264557116]

Moist Heat or Steam Sterilization


[04560264557116]

Moist Heat or Steam Sterilization


[04560264557116]

Moist Heat or Steam Sterilization


[04560264557116]

Moist Heat or Steam Sterilization


[04560264557116]

Moist Heat or Steam Sterilization


[04560264557116]

Moist Heat or Steam Sterilization


[04560264557116]

Moist Heat or Steam Sterilization


[04560264557116]

Moist Heat or Steam Sterilization


[04560264557116]

Moist Heat or Steam Sterilization


[04560264557116]

Moist Heat or Steam Sterilization


[04560264557116]

Moist Heat or Steam Sterilization


[04560264557116]

Moist Heat or Steam Sterilization


[04560264557116]

Moist Heat or Steam Sterilization


[04560264557116]

Moist Heat or Steam Sterilization


[04560264557116]

Moist Heat or Steam Sterilization


[04560264557116]

Moist Heat or Steam Sterilization


[04560264557116]

Moist Heat or Steam Sterilization


[04560264557116]

Moist Heat or Steam Sterilization


[04560264557116]

Moist Heat or Steam Sterilization


[04560264557116]

Moist Heat or Steam Sterilization


[04560264557116]

Moist Heat or Steam Sterilization


[04560264557116]

Moist Heat or Steam Sterilization


[04560264557116]

Moist Heat or Steam Sterilization


[04560264557116]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-02-25
Device Publish Date2022-02-17

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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.