Turbo-Power™ 423-050
GUDID 00813132022983
Turbo-Power™ Laser Atherectomy Catheter
Spectranetics Corporation
Atherectomy laser system beam guide-catheter, peripheral| Primary Device ID | 00813132022983 |
| NIH Device Record Key | 05508dbc-0e7d-4403-9dfb-c420b915f1cc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Turbo-Power™ |
| Version Model Number | 423-050 |
| 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 |
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 |
Device Dimensions
| 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 |
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 |
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00813132022983 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K152181
FDA Product Code
| MCW | Catheter, Peripheral, Atherectomy |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00813132022983]
Ethylene Oxide
[00813132022983]
Ethylene Oxide
[00813132022983]
Ethylene Oxide
[00813132022983]
Ethylene Oxide
[00813132022983]
Ethylene Oxide
[00813132022983]
Ethylene Oxide
[00813132022983]
Ethylene Oxide
[00813132022983]
Ethylene Oxide
[00813132022983]
Ethylene Oxide
[00813132022983]
Ethylene Oxide
[00813132022983]
Ethylene Oxide
[00813132022983]
Ethylene Oxide
[00813132022983]
Ethylene Oxide
[00813132022983]
Ethylene Oxide
[00813132022983]
Ethylene Oxide
[00813132022983]
Ethylene Oxide
[00813132022983]
Ethylene Oxide
[00813132022983]
Ethylene Oxide
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2015-11-14 |
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 |
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