AS2000 B2/B3

GUDID 04560224977190

NAKANISHI INC.

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Primary Device ID	04560224977190
NIH Device Record Key	662365c3-817d-4f1c-869d-6ba073d32145
Commercial Distribution Status	In Commercial Distribution
Brand Name	AS2000 B2/B3
Version Model Number	AS2000 B2/B3
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	04560224977190 [Primary]
GS1	04560264557376 [Direct Marking]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K991021

FDA Product Code

ELC	Scaler, ultrasonic