ZYE-ULTRA FDA 31303

GUDID 07898786930030

Multi-modality skin surface treatment system

Primary Device ID	07898786930030
NIH Device Record Key	fce62e65-269b-4763-a146-097805d1acff
Commercial Distribution Status	In Commercial Distribution
Brand Name	ZYE-ULTRA FDA
Version Model Number	31303
Catalog Number	31303
Company DUNS	904013281
Company Name	VYDENCE MEDICAL
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

Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between -5 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between -5 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between -5 Degrees Celsius and 70 Degrees Celsius

Device Issuing Agency	Device ID
GS1	07898786930030 [Primary]

GEX	Powered Laser Surgical Instrument

Steralize Prior To Use	false
Device Is Sterile	false