Fraxis Main Unit

GUDID 08800016903966

Dermatological carbon dioxide laser system

Primary Device ID	08800016903966
NIH Device Record Key	bb7ecfed-d56d-44f9-a8fa-908c3e04e283
Commercial Distribution Status	In Commercial Distribution
Brand Name	Fraxis Main Unit
Version Model Number	FRX-C1
Company DUNS	689842183
Company Name	CLASSYS 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	false
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	08800016903966 [Primary]
GS1	08800023200881 [Previous]

GEX	Powered Laser Surgical Instrument

Steralize Prior To Use	false
Device Is Sterile	false