F10R

GUDID 04560264573567

NAKANISHI INC.

Dental surgical power tool motorized handpiece/set, electric Dental surgical power tool motorized handpiece/set, electric Dental surgical power tool motorized handpiece/set, electric Dental surgical power tool motorized handpiece/set, electric Dental surgical power tool motorized handpiece/set, electric Dental surgical power tool motorized handpiece/set, electric Dental surgical power tool motorized handpiece/set, electric Dental surgical power tool motorized handpiece/set, electric Dental surgical power tool motorized handpiece/set, electric Dental surgical power tool motorized handpiece/set, electric Dental surgical power tool motorized handpiece/set, electric Dental surgical power tool motorized handpiece/set, electric Dental surgical power tool motorized handpiece/set, electric Dental surgical power tool motorized handpiece/set, electric Dental surgical power tool motorized handpiece/set, electric Dental surgical power tool motorized handpiece/set, electric Dental surgical power tool motorized handpiece/set, electric
Primary Device ID04560264573567
NIH Device Record Key87435558-be05-49b6-bb98-e1bc06416dab
Commercial Distribution StatusIn Commercial Distribution
Brand NameF10R
Version Model NumberF10R
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
GS104560264573567 [Primary]
GS104589551383139 [Direct Marking]

FDA Product Code

EKXHandpiece, direct drive, ac-powered

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04560264573567]

Moist Heat or Steam Sterilization


[04560264573567]

Moist Heat or Steam Sterilization


[04560264573567]

Moist Heat or Steam Sterilization


[04560264573567]

Moist Heat or Steam Sterilization


[04560264573567]

Moist Heat or Steam Sterilization


[04560264573567]

Moist Heat or Steam Sterilization


[04560264573567]

Moist Heat or Steam Sterilization


[04560264573567]

Moist Heat or Steam Sterilization


[04560264573567]

Moist Heat or Steam Sterilization


[04560264573567]

Moist Heat or Steam Sterilization


[04560264573567]

Moist Heat or Steam Sterilization


[04560264573567]

Moist Heat or Steam Sterilization


[04560264573567]

Moist Heat or Steam Sterilization


[04560264573567]

Moist Heat or Steam Sterilization


[04560264573567]

Moist Heat or Steam Sterilization


[04560264573567]

Moist Heat or Steam Sterilization


[04560264573567]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2022-11-25
Device Publish Date2020-11-07

On-Brand Devices [F10R]

04560224970634F10R
04560264573567F10R

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