097410

GUDID 01816901021643

Urogenital surgical laser system beam guide, single-use

Primary Device ID	01816901021643
NIH Device Record Key	bd96a5f9-9e5c-4cab-9cc8-d683e9303f6c
Commercial Distribution Status	In Commercial Distribution
Version Model Number	RE-1000-DO
Catalog Number	097410
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	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	00816901021644 [Primary]
GS1	01816901021643 [Package] Contains: 00816901021644 Package: [5 Units] In Commercial Distribution

GEX	Powered laser surgical instrument

Steralize Prior To Use	false
Device Is Sterile	true