P300-2S40

GUDID 04589551355334

NAKANISHI INC.

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Primary Device ID	04589551355334
NIH Device Record Key	82705da3-9995-40ba-a6de-30b6e55e860e
Commercial Distribution Status	In Commercial Distribution
Brand Name	P300-2S40
Version Model Number	P300-2S40
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	04589551355303 [Primary]
GS1	04589551355334 [Direct Marking]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K202120

FDA Product Code

HBE	DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)