KCL Coupling Wrench

GUDID 04560264576766

NAKANISHI INC.

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Primary Device ID	04560264576766
NIH Device Record Key	d021cb08-8fc6-4634-b2df-d619b94ea21f
Commercial Distribution Status	In Commercial Distribution
Brand Name	KCL Coupling Wrench
Version Model Number	KCL Coupling Wrench
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	true
Serial Number	false
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	04560264576735 [Primary]
GS1	04560264576766 [Direct Marking]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K203791

FDA Product Code

EFB	Handpiece, air-powered, dental