Primary Device ID | 00813132027452 |
NIH Device Record Key | 92448e08-4d46-48cf-8394-6f03df0a1196 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Philips Laser System |
Version Model Number | LAS-100 |
Catalog Number | LAS-100 |
Company DUNS | 151047370 |
Company Name | Spectranetics Corporation |
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 |
Phone | 1-800-633-0960 |
complaints@spnc.com | |
Phone | 1-800-633-0960 |
complaints@spnc.com | |
Phone | 1-800-633-0960 |
complaints@spnc.com | |
Phone | 1-800-633-0960 |
complaints@spnc.com | |
Phone | 1-800-633-0960 |
complaints@spnc.com | |
Phone | 1-800-633-0960 |
complaints@spnc.com | |
Phone | 1-800-633-0960 |
complaints@spnc.com | |
Phone | 1-800-633-0960 |
complaints@spnc.com | |
Phone | 1-800-633-0960 |
complaints@spnc.com | |
Phone | 1-800-633-0960 |
complaints@spnc.com | |
Phone | 1-800-633-0960 |
complaints@spnc.com | |
Phone | 1-800-633-0960 |
complaints@spnc.com | |
Phone | 1-800-633-0960 |
complaints@spnc.com | |
Phone | 1-800-633-0960 |
complaints@spnc.com | |
Phone | 1-800-633-0960 |
complaints@spnc.com | |
Phone | 1-800-633-0960 |
complaints@spnc.com | |
Phone | 1-800-633-0960 |
complaints@spnc.com | |
Phone | 1-800-633-0960 |
complaints@spnc.com | |
Phone | 1-800-633-0960 |
complaints@spnc.com | |
Phone | 1-800-633-0960 |
complaints@spnc.com | |
Phone | 1-800-633-0960 |
complaints@spnc.com | |
Phone | 1-800-633-0960 |
complaints@spnc.com | |
Phone | 1-800-633-0960 |
complaints@spnc.com | |
Phone | 1-800-633-0960 |
complaints@spnc.com | |
Phone | 1-800-633-0960 |
complaints@spnc.com | |
Phone | 1-800-633-0960 |
complaints@spnc.com | |
Phone | 1-800-633-0960 |
complaints@spnc.com | |
Phone | 1-800-633-0960 |
complaints@spnc.com | |
Phone | 1-800-633-0960 |
complaints@spnc.com | |
Phone | 1-800-633-0960 |
complaints@spnc.com | |
Phone | 1-800-633-0960 |
complaints@spnc.com | |
Phone | 1-800-633-0960 |
complaints@spnc.com | |
Phone | 1-800-633-0960 |
complaints@spnc.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00813132027452 [Primary] |
LPC | Device, Angioplasty, Laser, Coronary |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2021-09-28 |
Device Publish Date | 2021-09-20 |
00813132029944 - Turbo-Power | 2023-12-20 Turbo-Power Laser Atherectomy Catheter, 2.0mm |
00813132029951 - Turbo-Power | 2023-12-20 Turbo-Power Laser Atherectomy Catheter, 2.3mm |
00813132029937 - CVX-300 | 2022-10-20 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 |