InnoVoyce LLC KLF-001-400

GUDID 00860004755906

General/multiple surgical laser system beam guide, single-use

Primary Device ID	00860004755906
NIH Device Record Key	54c5d6c2-24d7-47d5-b5a7-0190eca7fc44
Commercial Distribution Status	In Commercial Distribution
Brand Name	InnoVoyce LLC
Version Model Number	A
Catalog Number	KLF-001-400
Company DUNS	118104468
Company Name	Innovoyce LLC
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	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	true
RX Perscription	true
OTC Over-The-Counter	false

Storage Environment Temperature	Between 10 Degrees Celsius and 37 Degrees Celsius
Storage Environment Temperature	Between 10 Degrees Celsius and 37 Degrees Celsius
Storage Environment Temperature	Between 10 Degrees Celsius and 37 Degrees Celsius
Storage Environment Temperature	Between 10 Degrees Celsius and 37 Degrees Celsius
Storage Environment Temperature	Between 10 Degrees Celsius and 37 Degrees Celsius
Storage Environment Temperature	Between 10 Degrees Celsius and 37 Degrees Celsius
Storage Environment Temperature	Between 10 Degrees Celsius and 37 Degrees Celsius
Storage Environment Temperature	Between 10 Degrees Celsius and 37 Degrees Celsius
Storage Environment Temperature	Between 10 Degrees Celsius and 37 Degrees Celsius
Storage Environment Temperature	Between 10 Degrees Celsius and 37 Degrees Celsius
Storage Environment Temperature	Between 10 Degrees Celsius and 37 Degrees Celsius
Storage Environment Temperature	Between 10 Degrees Celsius and 37 Degrees Celsius
Storage Environment Temperature	Between 10 Degrees Celsius and 37 Degrees Celsius
Storage Environment Temperature	Between 10 Degrees Celsius and 37 Degrees Celsius
Storage Environment Temperature	Between 10 Degrees Celsius and 37 Degrees Celsius
Storage Environment Temperature	Between 10 Degrees Celsius and 37 Degrees Celsius
Storage Environment Temperature	Between 10 Degrees Celsius and 37 Degrees Celsius

Device Issuing Agency	Device ID
GS1	00860004755906 [Primary]
GS1	20860004755900 [Package] Package: [5 Units] In Commercial Distribution

GEX	Powered Laser Surgical Instrument

Steralize Prior To Use	false
Device Is Sterile	true