S-Max pico KL

GUDID 04560264525061

NAKANISHI INC.

Dental surgical power tool motorized handpiece/set, pneumatic
Primary Device ID04560264525061
NIH Device Record Keyf43d874c-f92f-4613-9a8e-e1e1b9f07b05
Commercial Distribution StatusIn Commercial Distribution
Brand NameS-Max pico KL
Version Model NumberS-Max pico KL
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 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
GS104560264525061 [Direct Marking]
GS104560264574588 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EFBHandpiece, air-powered, dental

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04560264525061]

Moist Heat or Steam Sterilization


[04560264525061]

Moist Heat or Steam Sterilization


[04560264525061]

Moist Heat or Steam Sterilization


[04560264525061]

Moist Heat or Steam Sterilization


[04560264525061]

Moist Heat or Steam Sterilization


[04560264525061]

Moist Heat or Steam Sterilization


[04560264525061]

Moist Heat or Steam Sterilization


[04560264525061]

Moist Heat or Steam Sterilization


[04560264525061]

Moist Heat or Steam Sterilization


[04560264525061]

Moist Heat or Steam Sterilization


[04560264525061]

Moist Heat or Steam Sterilization


[04560264525061]

Moist Heat or Steam Sterilization


[04560264525061]

Moist Heat or Steam Sterilization


[04560264525061]

Moist Heat or Steam Sterilization


[04560264525061]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-11-01
Device Publish Date2022-10-24

On-Brand Devices [S-Max pico KL]

04560264573116S-Max pico KL
04560264524064S-Max pico KL
04560264525061S-Max pico KL

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