P300-2A80

GUDID 04589551355228

NAKANISHI INC.

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Primary Device ID	04589551355228
NIH Device Record Key	4b33e8cf-651c-4f76-a5f1-439e2a5a1860
Commercial Distribution Status	In Commercial Distribution
Brand Name	P300-2A80
Version Model Number	P300-2A80
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	true
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	04589551355167 [Primary]
GS1	04589551355228 [Direct Marking]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K202120

FDA Product Code

ERL	DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE