| 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 |