094126

GUDID 01816901021209

Urogenital surgical laser system beam guide, reusable

Primary Device ID	01816901021209
NIH Device Record Key	0350619b-1458-47de-9991-b766849a81c8
Commercial Distribution Status	In Commercial Distribution
Version Model Number	RE-550-DO
Catalog Number	094126
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	false
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	00816901021200 [Primary]
GS1	01816901021209 [Package] Contains: 00816901021200 Package: [5 Units] In Commercial Distribution

GEX	Powered laser surgical instrument

Steralize Prior To Use	false
Device Is Sterile	true