| Primary Device ID | M2044230010 |
| NIH Device Record Key | feca3737-0f66-4322-94f5-e82a4e594b5b |
| Commercial Distribution Discontinuation | 2019-02-06 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Turbo-Elite™ |
| Version Model Number | 423-001 |
| Catalog Number | 423-001 |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| 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 |
| Outer Diameter | 2.3 Millimeter |
| Outer Diameter | 2.3 Millimeter |
| Outer Diameter | 2.3 Millimeter |
| Outer Diameter | 2.3 Millimeter |
| Outer Diameter | 2.3 Millimeter |
| Outer Diameter | 2.3 Millimeter |
| Outer Diameter | 2.3 Millimeter |
| Outer Diameter | 2.3 Millimeter |
| Outer Diameter | 2.3 Millimeter |
| Outer Diameter | 2.3 Millimeter |
| Outer Diameter | 2.3 Millimeter |
| Outer Diameter | 2.3 Millimeter |
| Outer Diameter | 2.3 Millimeter |
| Outer Diameter | 2.3 Millimeter |
| Outer Diameter | 2.3 Millimeter |
| Outer Diameter | 2.3 Millimeter |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M2044230010 [Primary] |
| MCW | Catheter, Peripheral, Atherectomy |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[M2044230010]
Ethylene Oxide
[M2044230010]
Ethylene Oxide
[M2044230010]
Ethylene Oxide
[M2044230010]
Ethylene Oxide
[M2044230010]
Ethylene Oxide
[M2044230010]
Ethylene Oxide
[M2044230010]
Ethylene Oxide
[M2044230010]
Ethylene Oxide
[M2044230010]
Ethylene Oxide
[M2044230010]
Ethylene Oxide
[M2044230010]
Ethylene Oxide
[M2044230010]
Ethylene Oxide
[M2044230010]
Ethylene Oxide
[M2044230010]
Ethylene Oxide
[M2044230010]
Ethylene Oxide
[M2044230010]
Ethylene Oxide
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2021-10-26 |
| Device Publish Date | 2014-08-27 |
| M204425011AA0 | Turbo-Elite™ Laser Atherectomy Catheter |
| M204423001AA0 | Turbo-Elite™ Laser Atherectomy Catheter |
| M204420159AA0 | Turbo-Elite™ Laser Atherectomy Catheter |
| M204420006AA0 | Turbo-Elite™ Laser Atherectomy Catheter |
| M204417156AA0 | Turbo-Elite™ Laser Atherectomy Catheter |
| M204417152AA0 | Turbo-Elite™ Laser Atherectomy Catheter |
| M204414159AA0 | Turbo-Elite™ Laser Atherectomy Catheter |
| M204414151AA0 | Turbo-Elite™ Laser Atherectomy Catheter |
| M204410154AA0 | Turbo-Elite™ Laser Atherectomy Catheter |
| M204410152AA0 | Turbo-Elite™ Laser Atherectomy Catheter |
| M2044250010 | Turbo-Elite™ Laser Atherectomy Catheter |
| M2044230010 | Turbo-Elite™ Laser Atherectomy Catheter |
| M2044201590 | Turbo-Elite™ Laser Atherectomy Catheter |
| M2044200060 | Turbo-Elite™ Laser Atherectomy Catheter |
| M2044171560 | Turbo-Elite™ Laser Atherectomy Catheter |
| M2044171520 | Turbo-Elite™ Laser Atherectomy Catheter |
| M2044141590 | Turbo-Elite™ Laser Atherectomy Catheter |
| M2044141510 | Turbo-Elite™ Laser Atherectomy Catheter |
| M2044101540 | Turbo-Elite™ Laser Atherectomy Catheter |
| M2044101520 | Turbo-Elite™ Laser Atherectomy Catheter |