Philips Laser System LAS-100

GUDID 00813132027452

Excimer Laser System

Spectranetics Corporation

Atherectomy excimer laser system
Primary Device ID00813132027452
NIH Device Record Key92448e08-4d46-48cf-8394-6f03df0a1196
Commercial Distribution StatusIn Commercial Distribution
Brand NamePhilips Laser System
Version Model NumberLAS-100
Catalog NumberLAS-100
Company DUNS151047370
Company NameSpectranetics Corporation
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-633-0960
Emailcomplaints@spnc.com
Phone1-800-633-0960
Emailcomplaints@spnc.com
Phone1-800-633-0960
Emailcomplaints@spnc.com
Phone1-800-633-0960
Emailcomplaints@spnc.com
Phone1-800-633-0960
Emailcomplaints@spnc.com
Phone1-800-633-0960
Emailcomplaints@spnc.com
Phone1-800-633-0960
Emailcomplaints@spnc.com
Phone1-800-633-0960
Emailcomplaints@spnc.com
Phone1-800-633-0960
Emailcomplaints@spnc.com
Phone1-800-633-0960
Emailcomplaints@spnc.com
Phone1-800-633-0960
Emailcomplaints@spnc.com
Phone1-800-633-0960
Emailcomplaints@spnc.com
Phone1-800-633-0960
Emailcomplaints@spnc.com
Phone1-800-633-0960
Emailcomplaints@spnc.com
Phone1-800-633-0960
Emailcomplaints@spnc.com
Phone1-800-633-0960
Emailcomplaints@spnc.com
Phone1-800-633-0960
Emailcomplaints@spnc.com
Phone1-800-633-0960
Emailcomplaints@spnc.com
Phone1-800-633-0960
Emailcomplaints@spnc.com
Phone1-800-633-0960
Emailcomplaints@spnc.com
Phone1-800-633-0960
Emailcomplaints@spnc.com
Phone1-800-633-0960
Emailcomplaints@spnc.com
Phone1-800-633-0960
Emailcomplaints@spnc.com
Phone1-800-633-0960
Emailcomplaints@spnc.com
Phone1-800-633-0960
Emailcomplaints@spnc.com
Phone1-800-633-0960
Emailcomplaints@spnc.com
Phone1-800-633-0960
Emailcomplaints@spnc.com
Phone1-800-633-0960
Emailcomplaints@spnc.com
Phone1-800-633-0960
Emailcomplaints@spnc.com
Phone1-800-633-0960
Emailcomplaints@spnc.com
Phone1-800-633-0960
Emailcomplaints@spnc.com
Phone1-800-633-0960
Emailcomplaints@spnc.com
Phone1-800-633-0960
Emailcomplaints@spnc.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100813132027452 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LPCDevice, Angioplasty, Laser, Coronary

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-09-28
Device Publish Date2021-09-20

Devices Manufactured by Spectranetics Corporation

00813132029944 - Turbo-Power2023-12-20 Turbo-Power Laser Atherectomy Catheter, 2.0mm
00813132029951 - Turbo-Power2023-12-20 Turbo-Power Laser Atherectomy Catheter, 2.3mm
00813132029937 - CVX-3002022-10-20 Excimer Laser System
M2041100010 - ELCA™2021-10-26 ELCA™ Coronary Laser Atherectomy Catheter
M2041100020 - ELCA™2021-10-26 ELCA™ Coronary Laser Atherectomy Catheter
M2041100030 - ELCA™2021-10-26 ELCA™ Coronary Laser Atherectomy Catheter
M2041100040 - ELCA™2021-10-26 ELCA™ Coronary Laser Atherectomy Catheter
M2041140090 - ELCA™2021-10-26 ELCA™ Coronary Laser Atherectomy Catheter

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