093461

GUDID 01816901020042

Urogenital surgical laser system beam guide, single-use

Primary Device ID	01816901020042
NIH Device Record Key	996bc02d-0b06-4d1c-84cc-f89c65e7028d
Commercial Distribution Status	In Commercial Distribution
Version Model Number	SU-550
Catalog Number	093461
Company DUNS	967515367
Company Name	FORTEC FIBERS, 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	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	00816901020043 [Primary]
GS1	01816901020042 [Package] Contains: 00816901020043 Package: [5 Units] In Commercial Distribution

GEX	Powered laser surgical instrument

Steralize Prior To Use	false
Device Is Sterile	true