Root ZX3

GUDID 04548213056545

J.MORITA MFG.CORP.

Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system

Primary Device ID	04548213056545
NIH Device Record Key	1829e783-8c7c-4b2c-822f-404f3b605398
Commercial Distribution Status	In Commercial Distribution
Brand Name	Root ZX3
Version Model Number	RZX3 Type: HF
Company DUNS	693811465
Company Name	J.MORITA MFG.CORP.
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	04548213056545 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K213477

FDA Product Code

EKZ	Unit, Electrosurgical, And Accessories, Dental