New Star Lasers

GUDID 00859932006211

Fiber Optic Catheter

NEW STAR LASERS, INC.

General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system

Primary Device ID	00859932006211
NIH Device Record Key	f1f225e9-3358-4fa4-a3de-8980ce264f0b
Commercial Distribution Status	In Commercial Distribution
Brand Name	New Star Lasers
Version Model Number	7420-0013
Company DUNS	877266163
Company Name	NEW STAR LASERS, 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	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00859932006211 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K994273

FDA Product Code

GEX	Powered Laser Surgical Instrument