Digital AcuBlade™ for UltraPulse® SurgiTouch™

GUDID 07290109142951

LUMENIS LTD.

General/multiple surgical solid-state/carbon dioxide laser system General/multiple surgical solid-state/carbon dioxide laser system General/multiple surgical solid-state/carbon dioxide laser system General/multiple surgical solid-state/carbon dioxide laser system General/multiple surgical solid-state/carbon dioxide laser system General/multiple surgical solid-state/carbon dioxide laser system General/multiple surgical solid-state/carbon dioxide laser system General/multiple surgical solid-state/carbon dioxide laser system General/multiple surgical solid-state/carbon dioxide laser system General/multiple surgical solid-state/carbon dioxide laser system General/multiple surgical solid-state/carbon dioxide laser system General/multiple surgical solid-state/carbon dioxide laser system General/multiple surgical solid-state/carbon dioxide laser system General/multiple surgical solid-state/carbon dioxide laser system General/multiple surgical solid-state/carbon dioxide laser system General/multiple surgical solid-state/carbon dioxide laser system General/multiple surgical solid-state/carbon dioxide laser system ENT surgery micromanipulator ENT surgery micromanipulator ENT surgery micromanipulator ENT surgery micromanipulator ENT surgery micromanipulator ENT surgery micromanipulator ENT surgery micromanipulator ENT surgery micromanipulator ENT surgery micromanipulator ENT surgery micromanipulator ENT surgery micromanipulator ENT surgery micromanipulator ENT surgery micromanipulator ENT surgery micromanipulator ENT surgery micromanipulator ENT surgery micromanipulator ENT surgery micromanipulator

Primary Device ID	07290109142951
NIH Device Record Key	cffc67c1-fecf-4ef3-84d6-d4b11a79d5bd
Commercial Distribution Status	In Commercial Distribution
Brand Name	Digital AcuBlade™ for UltraPulse® SurgiTouch™
Version Model Number	Digital AcuBlade™ for UltraPulse® SurgiTouch™
Company DUNS	600166524
Company Name	LUMENIS LTD.
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	false
Serial Number	true
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

Customer Support Contacts

Phone	408-764-3000
Email	xxx@xxx.xxx
Phone	408-764-3000
Email	xxx@xxx.xxx
Phone	408-764-3000
Email	xxx@xxx.xxx
Phone	408-764-3000
Email	xxx@xxx.xxx
Phone	408-764-3000
Email	xxx@xxx.xxx
Phone	408-764-3000
Email	xxx@xxx.xxx
Phone	408-764-3000
Email	xxx@xxx.xxx
Phone	408-764-3000
Email	xxx@xxx.xxx
Phone	408-764-3000
Email	xxx@xxx.xxx
Phone	408-764-3000
Email	xxx@xxx.xxx
Phone	408-764-3000
Email	xxx@xxx.xxx
Phone	408-764-3000
Email	xxx@xxx.xxx
Phone	408-764-3000
Email	xxx@xxx.xxx
Phone	408-764-3000
Email	xxx@xxx.xxx
Phone	408-764-3000
Email	xxx@xxx.xxx
Phone	408-764-3000
Email	xxx@xxx.xxx
Phone	408-764-3000
Email	xxx@xxx.xxx
Phone	408-764-3000
Email	xxx@xxx.xxx
Phone	408-764-3000
Email	xxx@xxx.xxx
Phone	408-764-3000
Email	xxx@xxx.xxx
Phone	408-764-3000
Email	xxx@xxx.xxx
Phone	408-764-3000
Email	xxx@xxx.xxx
Phone	408-764-3000
Email	xxx@xxx.xxx
Phone	408-764-3000
Email	xxx@xxx.xxx
Phone	408-764-3000
Email	xxx@xxx.xxx
Phone	408-764-3000
Email	xxx@xxx.xxx
Phone	408-764-3000
Email	xxx@xxx.xxx
Phone	408-764-3000
Email	xxx@xxx.xxx
Phone	408-764-3000
Email	xxx@xxx.xxx
Phone	408-764-3000
Email	xxx@xxx.xxx
Phone	408-764-3000
Email	xxx@xxx.xxx
Phone	408-764-3000
Email	xxx@xxx.xxx
Phone	408-764-3000
Email	xxx@xxx.xxx
Phone	408-764-3000
Email	xxx@xxx.xxx

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290109142951 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K151331

FDA Product Code

GEX	Powered Laser Surgical Instrument