097464

GUDID 02816901022885

Urogenital surgical laser system beam guide, single-use

Primary Device ID	02816901022885
NIH Device Record Key	5b655cbf-e209-4987-956b-1c8d7dea5ab6
Commercial Distribution Status	In Commercial Distribution
Version Model Number	LFS-550-RT
Catalog Number	097464
Company DUNS	039281260
Company Name	LEONI FIBER OPTICS, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	MR Unsafe
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	false
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	00816901022887 [Primary]
GS1	01816901022886 [Package] Contains: 00816901022887 Package: [5 Units] In Commercial Distribution
GS1	02816901022885 [Package] Contains: 01816901022886 Package: [2 Units] In Commercial Distribution

GEX	Powered laser surgical instrument

Steralize Prior To Use	false
Device Is Sterile	true