MI Starter Kit

GUDID 04560264562943

NAKANISHI INC.

Ultrasonic dental scaling/debridement system handpiece tip, periodontal
Primary Device ID04560264562943
NIH Device Record Key43d048cb-a61e-4e40-8f6a-8e5cdc5d649e
Commercial Distribution StatusIn Commercial Distribution
Brand NameMI Starter Kit
Version Model NumberMI Starter Kit
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 Batchtrue
Serial Numberfalse
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
GS104560264562943 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ELCScaler, ultrasonic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04560264562943]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-16

Devices Manufactured by NAKANISHI INC.

04560264500730 - Primado22024-04-03
04560264500747 - Primado22024-04-03
04560264511668 - Primado22024-04-03
04560264511675 - Primado22024-04-03
04560264511705 - Primado22024-04-03
04560264511736 - Primado22024-04-03
04560264523081 - Primado22024-04-03
04560264523098 - Primado22024-04-03

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