iSD900

GUDID 04560264573291

NAKANISHI INC.

Power tool torque control unit Power tool torque control unit Power tool torque control unit Power tool torque control unit Power tool torque control unit Power tool torque control unit Power tool torque control unit Power tool torque control unit Power tool torque control unit Power tool torque control unit Power tool torque control unit Power tool torque control unit Power tool torque control unit Power tool torque control unit Power tool torque control unit Power tool torque control unit Power tool torque control unit

Primary Device ID	04560264573291
NIH Device Record Key	5bc88fb7-9b50-4a2c-8ab1-3217c2e0a30a
Commercial Distribution Status	In Commercial Distribution
Brand Name	iSD900
Version Model Number	iSD900
Company DUNS	690710546
Company Name	NAKANISHI INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04560264573291 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K110278

FDA Product Code

EKX	Handpiece, direct drive, ac-powered