Turbo-Power™ 420-050
GUDID 00813132026783
Turbo-Power™ Laser Atherectomy Catheter
Spectranetics Corporation
Atherectomy laser system beam guide-catheter, peripheral| Primary Device ID | 00813132026783 |
| NIH Device Record Key | 13ec4ace-4a8e-4ea9-815e-7df14adef786 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Turbo-Power™ |
| Version Model Number | 420-050AB |
| Catalog Number | 420-050 |
| 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 |
Customer Support Contacts
| 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 |
Device Dimensions
| Outer Diameter | 2 Millimeter |
| Outer Diameter | 2 Millimeter |
| Outer Diameter | 2 Millimeter |
| Outer Diameter | 2 Millimeter |
| Outer Diameter | 2 Millimeter |
| Outer Diameter | 2 Millimeter |
| Outer Diameter | 2 Millimeter |
| Outer Diameter | 2 Millimeter |
| Outer Diameter | 2 Millimeter |
| Outer Diameter | 2 Millimeter |
| Outer Diameter | 2 Millimeter |
| Outer Diameter | 2 Millimeter |
| Outer Diameter | 2 Millimeter |
| Outer Diameter | 2 Millimeter |
| Outer Diameter | 2 Millimeter |
| Outer Diameter | 2 Millimeter |
| Outer Diameter | 2 Millimeter |
| Outer Diameter | 2 Millimeter |
| Outer Diameter | 2 Millimeter |
| Length | 150 Centimeter |
| Outer Diameter | 2 Millimeter |
| Length | 150 Centimeter |
| Outer Diameter | 2 Millimeter |
| Length | 150 Centimeter |
| Outer Diameter | 2 Millimeter |
| Length | 150 Centimeter |
| Outer Diameter | 2 Millimeter |
| Length | 150 Centimeter |
| Outer Diameter | 2 Millimeter |
| Length | 150 Centimeter |
| Outer Diameter | 2 Millimeter |
| Length | 150 Centimeter |
| Outer Diameter | 2 Millimeter |
| Length | 150 Centimeter |
| Outer Diameter | 2 Millimeter |
| Length | 150 Centimeter |
| Outer Diameter | 2 Millimeter |
| Length | 150 Centimeter |
| Outer Diameter | 2 Millimeter |
| Length | 150 Centimeter |
| Outer Diameter | 2 Millimeter |
| Length | 150 Centimeter |
| Outer Diameter | 2 Millimeter |
| Length | 150 Centimeter |
| Outer Diameter | 2 Millimeter |
| Length | 150 Centimeter |
| Outer Diameter | 2 Millimeter |
| Length | 150 Centimeter |
| Outer Diameter | 2 Millimeter |
| Length | 150 Centimeter |
| Outer Diameter | 2 Millimeter |
| Length | 150 Centimeter |
| Outer Diameter | 2 Millimeter |
| Length | 150 Centimeter |
| Outer Diameter | 2 Millimeter |
| Length | 150 Centimeter |
| Outer Diameter | 2 Millimeter |
| Length | 150 Centimeter |
| Outer Diameter | 2 Millimeter |
| Length | 150 Centimeter |
| Outer Diameter | 2 Millimeter |
| Length | 150 Centimeter |
| Outer Diameter | 2 Millimeter |
| Length | 150 Centimeter |
| Outer Diameter | 2 Millimeter |
| Length | 150 Centimeter |
| Outer Diameter | 2 Millimeter |
| Length | 150 Centimeter |
| Outer Diameter | 2 Millimeter |
| Length | 150 Centimeter |
| Outer Diameter | 2 Millimeter |
| Length | 150 Centimeter |
| Outer Diameter | 2 Millimeter |
| Length | 150 Centimeter |
| Outer Diameter | 2 Millimeter |
| Length | 150 Centimeter |
| Outer Diameter | 2 Millimeter |
| Length | 150 Centimeter |
| Outer Diameter | 2 Millimeter |
| Length | 150 Centimeter |
| Outer Diameter | 2 Millimeter |
| Length | 150 Centimeter |
| Outer Diameter | 2 Millimeter |
| Length | 150 Centimeter |
| Outer Diameter | 2 Millimeter |
| Length | 150 Centimeter |
| Outer Diameter | 2 Millimeter |
| Length | 150 Centimeter |
| Outer Diameter | 2 Millimeter |
| Length | 150 Centimeter |
| Outer Diameter | 2 Millimeter |
| Length | 150 Centimeter |
| Outer Diameter | 2 Millimeter |
| Length | 150 Centimeter |
| Outer Diameter | 2 Millimeter |
| Length | 150 Centimeter |
| Outer Diameter | 2 Millimeter |
| Length | 150 Centimeter |
| Outer Diameter | 2 Millimeter |
| Length | 150 Centimeter |
| Outer Diameter | 2 Millimeter |
| Length | 150 Centimeter |
| Outer Diameter | 2 Millimeter |
| Length | 150 Centimeter |
| Outer Diameter | 2 Millimeter |
| Length | 150 Centimeter |
| Outer Diameter | 2 Millimeter |
| Length | 150 Centimeter |
| Outer Diameter | 2 Millimeter |
| Length | 150 Centimeter |
Operating and Storage Conditions
| 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 |
| 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00813132026783 [Primary] |
FDA Product Code
| MCW | Catheter, Peripheral, Atherectomy |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00813132026783]
Ethylene Oxide
[00813132026783]
Ethylene Oxide
[00813132026783]
Ethylene Oxide
[00813132026783]
Ethylene Oxide
[00813132026783]
Ethylene Oxide
[00813132026783]
Ethylene Oxide
[00813132026783]
Ethylene Oxide
[00813132026783]
Ethylene Oxide
[00813132026783]
Ethylene Oxide
[00813132026783]
Ethylene Oxide
[00813132026783]
Ethylene Oxide
[00813132026783]
Ethylene Oxide
[00813132026783]
Ethylene Oxide
[00813132026783]
Ethylene Oxide
[00813132026783]
Ethylene Oxide
[00813132026783]
Ethylene Oxide
[00813132026783]
Ethylene Oxide
[00813132026783]
Ethylene Oxide
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-12-31 |
| Device Publish Date | 2018-11-29 |
On-Brand Devices [Turbo-Power™]
| 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 |
Trademark Results [Turbo-Power]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TURBO-POWER 86701531 4966361 Live/Registered |
The Spectranetics Corporation 2015-07-22 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.