Viva-mate

GUDID 04560224971617

NAKANISHI INC.

Dental surgical power tool motor, electric
Primary Device ID04560224971617
NIH Device Record Key2d5890f0-3eac-43e6-ad33-21ccae215494
Commercial Distribution StatusIn Commercial Distribution
Brand NameViva-mate
Version Model NumberViva-mate Motor
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
GS104560224971617 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EKXHandpiece, direct drive, ac-powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2023-10-12
Device Publish Date2020-06-12

On-Brand Devices [Viva-mate]

04560264540422VIVA-MATE Motor Cord
04560224971617Viva-mate Motor

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