iSD900

GUDID 04560264521865

NAKANISHI INC.

Surgical screwdriver, reusable
Primary Device ID04560264521865
NIH Device Record Key9f9ae25f-cdce-42f4-b12f-48e166e47df1
Commercial Distribution StatusIn Commercial Distribution
Brand NameiSD900
Version Model NumberiSD900 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
GS104560264521865 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-06-29
Device Publish Date2020-06-19

On-Brand Devices [iSD900]

04560264521865iSD900 Motor
04560264522329Quick Charger for iSD900
04560264573291iSD900
04560264574212Quick Charger for iSD900

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