095318

GUDID 02816901022052

Urogenital surgical laser system beam guide, single-use

Primary Device ID	02816901022052
NIH Device Record Key	b22f3667-f55c-4bcb-83c9-1072e0dce673
Commercial Distribution Discontinuation	2021-06-01
Commercial Distribution Status	Not in Commercial Distribution
Version Model Number	LFS-365-RT
Catalog Number	095318
Company DUNS	039281260
Company Name	LEONI FIBER OPTICS, 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	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
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	00816901022054 [Primary]
GS1	01816901022053 [Package] Contains: 00816901022054 Package: [5 Units] Discontinued: 2021-06-01 Not in Commercial Distribution
GS1	02816901022052 [Package] Contains: 01816901022053 Package: [2 Units] Discontinued: 2021-06-01 Not in Commercial Distribution

GEX	Powered laser surgical instrument

Steralize Prior To Use	false
Device Is Sterile	true