S-Max M

GUDID 04560264529212

NAKANISHI INC.

Dental power tool system handpiece, line-powered Dental power tool system handpiece, line-powered Dental power tool system handpiece, line-powered Dental power tool system handpiece, line-powered Dental power tool system handpiece, line-powered Dental power tool system handpiece, line-powered Dental power tool system handpiece, line-powered Dental power tool system handpiece, line-powered Dental power tool system handpiece, line-powered Dental power tool system handpiece, line-powered Dental power tool system handpiece, line-powered Dental power tool system handpiece, line-powered Dental power tool system handpiece, line-powered Dental power tool system handpiece, line-powered Dental power tool system handpiece, line-powered Dental power tool system handpiece, line-powered Dental power tool system handpiece, line-powered
Primary Device ID04560264529212
NIH Device Record Key45648fb8-3f85-4654-be4f-3c5a7fa73ee9
Commercial Distribution StatusIn Commercial Distribution
Brand NameS-Max M
Version Model NumberSG20
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
GS104560264529212 [Primary]
GS104560264557123 [Direct Marking]

FDA Product Code

KMWHANDPIECE, ROTARY BONE CUTTING

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04560264529212]

Moist Heat or Steam Sterilization


[04560264529212]

Moist Heat or Steam Sterilization


[04560264529212]

Moist Heat or Steam Sterilization


[04560264529212]

Moist Heat or Steam Sterilization


[04560264529212]

Moist Heat or Steam Sterilization


[04560264529212]

Moist Heat or Steam Sterilization


[04560264529212]

Moist Heat or Steam Sterilization


[04560264529212]

Moist Heat or Steam Sterilization


[04560264529212]

Moist Heat or Steam Sterilization


[04560264529212]

Moist Heat or Steam Sterilization


[04560264529212]

Moist Heat or Steam Sterilization


[04560264529212]

Moist Heat or Steam Sterilization


[04560264529212]

Moist Heat or Steam Sterilization


[04560264529212]

Moist Heat or Steam Sterilization


[04560264529212]

Moist Heat or Steam Sterilization


[04560264529212]

Moist Heat or Steam Sterilization


[04560264529212]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-11-22
Device Publish Date2016-09-16

On-Brand Devices [S-Max M]

04560264560093SG20
04560264557123SG20
04560264529212SG20

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