AS2000 M4

GUDID 04560264562158

NAKANISHI INC.

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Primary Device ID	04560264562158
NIH Device Record Key	bb085121-7c3f-4a61-a30f-c39c392a158e
Commercial Distribution Status	In Commercial Distribution
Brand Name	AS2000 M4
Version Model Number	AS2000 M4
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	04560264557383 [Direct Marking]
GS1	04560264562158 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K991021

FDA Product Code

ELC	Scaler, ultrasonic