ReNew XR Handpiece with Reference Length Markings

GUDID 00811099014300

MICROLINE SURGICAL, INC.

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Primary Device ID	00811099014300
NIH Device Record Key	a2967ac1-4261-4433-b991-ad7cc4eda2ca
Commercial Distribution Status	In Commercial Distribution
Brand Name	ReNew XR Handpiece with Reference Length Markings
Version Model Number	3945M
Company DUNS	184080570
Company Name	MICROLINE SURGICAL, 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	true
RX Perscription	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00811099014300 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K234147

FDA Product Code

GEI	Electrosurgical, Cutting & Coagulation & Accessories