| Primary Device ID | 00813132026776 |
| NIH Device Record Key | 38f0832d-18fb-45a0-896c-fd63b49ea2e3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Turbo-Power™ |
| Version Model Number | 423-050AB |
| Catalog Number | 423-050 |
| 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 | |
| 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 | (800) 228-4728 |
| IGTD.CustomerInquiry@philips.com | |
| Phone | (800) 228-4728 |
| IGTD.CustomerInquiry@philips.com | |
| Phone | (800) 228-4728 |
| IGTD.CustomerInquiry@philips.com | |
| Phone | (800) 228-4728 |
| IGTD.CustomerInquiry@philips.com | |
| Phone | (800) 228-4728 |
| IGTD.CustomerInquiry@philips.com | |
| Phone | (800) 228-4728 |
| IGTD.CustomerInquiry@philips.com | |
| Phone | (800) 228-4728 |
| IGTD.CustomerInquiry@philips.com | |
| Phone | (800) 228-4728 |
| IGTD.CustomerInquiry@philips.com | |
| Phone | (800) 228-4728 |
| IGTD.CustomerInquiry@philips.com | |
| Phone | (800) 228-4728 |
| IGTD.CustomerInquiry@philips.com | |
| Phone | (800) 228-4728 |
| IGTD.CustomerInquiry@philips.com | |
| Phone | (800) 228-4728 |
| IGTD.CustomerInquiry@philips.com | |
| Phone | (800) 228-4728 |
| IGTD.CustomerInquiry@philips.com | |
| Phone | (800) 228-4728 |
| IGTD.CustomerInquiry@philips.com | |
| Phone | (800) 228-4728 |
| IGTD.CustomerInquiry@philips.com | |
| Phone | (800) 228-4728 |
| IGTD.CustomerInquiry@philips.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 |
| Outer Diameter | 2.3 Millimeter |
| Outer Diameter | 2.3 Millimeter |
| Outer Diameter | 2.3 Millimeter |
| Length | 125 Centimeter |
| Outer Diameter | 2.3 Millimeter |
| Length | 125 Centimeter |
| Outer Diameter | 2.3 Millimeter |
| Length | 125 Centimeter |
| Outer Diameter | 2.3 Millimeter |
| Length | 125 Centimeter |
| Outer Diameter | 2.3 Millimeter |
| Length | 125 Centimeter |
| Outer Diameter | 2.3 Millimeter |
| Length | 125 Centimeter |
| Outer Diameter | 2.3 Millimeter |
| Length | 125 Centimeter |
| Outer Diameter | 2.3 Millimeter |
| Length | 125 Centimeter |
| Outer Diameter | 2.3 Millimeter |
| Length | 125 Centimeter |
| Outer Diameter | 2.3 Millimeter |
| Length | 125 Centimeter |
| Outer Diameter | 2.3 Millimeter |
| Length | 125 Centimeter |
| Outer Diameter | 2.3 Millimeter |
| Length | 125 Centimeter |
| Outer Diameter | 2.3 Millimeter |
| Length | 125 Centimeter |
| Outer Diameter | 2.3 Millimeter |
| Length | 125 Centimeter |
| Outer Diameter | 2.3 Millimeter |
| Length | 125 Centimeter |
| Outer Diameter | 2.3 Millimeter |
| Length | 125 Centimeter |
| Outer Diameter | 2.3 Millimeter |
| Length | 125 Centimeter |
| Outer Diameter | 2.3 Millimeter |
| Length | 125 Centimeter |
| Outer Diameter | 2.3 Millimeter |
| Length | 125 Centimeter |
| Outer Diameter | 2.3 Millimeter |
| Length | 125 Centimeter |
| Outer Diameter | 2.3 Millimeter |
| Length | 125 Centimeter |
| Outer Diameter | 2.3 Millimeter |
| Length | 125 Centimeter |
| Outer Diameter | 2.3 Millimeter |
| Length | 125 Centimeter |
| Outer Diameter | 2.3 Millimeter |
| Length | 125 Centimeter |
| Outer Diameter | 2.3 Millimeter |
| Length | 125 Centimeter |
| Outer Diameter | 2.3 Millimeter |
| Length | 125 Centimeter |
| Outer Diameter | 2.3 Millimeter |
| Length | 125 Centimeter |
| Outer Diameter | 2.3 Millimeter |
| Length | 125 Centimeter |
| Outer Diameter | 2.3 Millimeter |
| Length | 125 Centimeter |
| Outer Diameter | 2.3 Millimeter |
| Length | 125 Centimeter |
| Outer Diameter | 2.3 Millimeter |
| Length | 125 Centimeter |
| Outer Diameter | 2.3 Millimeter |
| Length | 125 Centimeter |
| Outer Diameter | 2.3 Millimeter |
| Length | 125 Centimeter |
| Outer Diameter | 2.3 Millimeter |
| Length | 125 Centimeter |
| Outer Diameter | 2.3 Millimeter |
| Length | 125 Centimeter |
| Outer Diameter | 2.3 Millimeter |
| Length | 125 Centimeter |
| Outer Diameter | 2.3 Millimeter |
| Length | 125 Centimeter |
| Outer Diameter | 2.3 Millimeter |
| Length | 125 Centimeter |
| Outer Diameter | 2.3 Millimeter |
| Length | 125 Centimeter |
| Outer Diameter | 2.3 Millimeter |
| Length | 125 Centimeter |
| Outer Diameter | 2.3 Millimeter |
| Length | 125 Centimeter |
| Outer Diameter | 2.3 Millimeter |
| Length | 125 Centimeter |
| Outer Diameter | 2.3 Millimeter |
| Length | 125 Centimeter |
| Outer Diameter | 2.3 Millimeter |
| Length | 125 Centimeter |
| Outer Diameter | 2.3 Millimeter |
| Length | 125 Centimeter |
| Outer Diameter | 2.3 Millimeter |
| Length | 125 Centimeter |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00813132026776 [Primary] |
| MCW | Catheter, Peripheral, Atherectomy |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00813132026776]
Ethylene Oxide
[00813132026776]
Ethylene Oxide
[00813132026776]
Ethylene Oxide
[00813132026776]
Ethylene Oxide
[00813132026776]
Ethylene Oxide
[00813132026776]
Ethylene Oxide
[00813132026776]
Ethylene Oxide
[00813132026776]
Ethylene Oxide
[00813132026776]
Ethylene Oxide
[00813132026776]
Ethylene Oxide
[00813132026776]
Ethylene Oxide
[00813132026776]
Ethylene Oxide
[00813132026776]
Ethylene Oxide
[00813132026776]
Ethylene Oxide
[00813132026776]
Ethylene Oxide
[00813132026776]
Ethylene Oxide
[00813132026776]
Ethylene Oxide
[00813132026776]
Ethylene Oxide
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-12-31 |
| Device Publish Date | 2018-11-29 |
| 00813132026783 | Turbo-Power™ Laser Atherectomy Catheter |
| 00813132026776 | Turbo-Power™ Laser Atherectomy Catheter |
| 00813132025397 | Turbo-Power™ Laser Atherectomy Catheter |
| 00813132025366 | Turbo-Power™ Laser Atherectomy Catheter |
| 00813132024833 | Turbo-Power™ Laser Atherectomy Catheter |
| 00813132022983 | Turbo-Power™ Laser Atherectomy Catheter |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() TURBO-POWER 86701531 4966361 Live/Registered |
The Spectranetics Corporation 2015-07-22 |