| Primary Device ID | 20813132020488 | 
| NIH Device Record Key | 950dead5-344c-4f29-9354-40c8237c4997 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Quick-Cross™Select | 
| Version Model Number | 518-079AA | 
| Catalog Number | 518-079 | 
| 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 | 
| Length | 90 Centimeter | 
| Length | 90 Centimeter | 
| Length | 90 Centimeter | 
| Length | 90 Centimeter | 
| Length | 90 Centimeter | 
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| Length | 90 Centimeter | 
| Length | 90 Centimeter | 
| Length | 90 Centimeter | 
| Length | 90 Centimeter | 
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| Length | 90 Centimeter | 
| Length | 90 Centimeter | 
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| Length | 90 Centimeter | 
| Length | 90 Centimeter | 
| Length | 90 Centimeter | 
| Length | 90 Centimeter | 
| Length | 90 Centimeter | 
| Length | 90 Centimeter | 
| Length | 90 Centimeter | 
| Length | 90 Centimeter | 
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| Length | 90 Centimeter | 
| Length | 90 Centimeter | 
| Length | 90 Centimeter | 
| Length | 90 Centimeter | 
| Length | 90 Centimeter | 
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| Length | 90 Centimeter | 
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| Length | 90 Centimeter | 
| Length | 90 Centimeter | 
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit | 
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit | 
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit | 
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | 
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | 
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | 
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | 
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | 
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | 
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | 
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | 
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | 
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | 
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | 
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | 
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | 
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | 
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | 
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | 
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | 
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | 
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | 
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | 
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | 
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | 
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | 
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | 
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | 
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | 
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | 
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | 
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | 
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | 
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | 
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | 
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | 
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | 
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | 
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | 
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | 
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | 
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | 
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | 
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | 
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | 
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | 
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | 
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 00813132020484 [Primary] | 
| GS1 | 20813132020488 [Package] Contains: 00813132020484 Package: Box [5 Units] In Commercial Distribution | 
| HIBCC | M204518079AA0 [Secondary] | 
| DQY | Catheter, Percutaneous | 
| Steralize Prior To Use | true | 
| Device Is Sterile | true | 
[20813132020488]
Ethylene Oxide
[20813132020488]
Ethylene Oxide
[20813132020488]
Ethylene Oxide
[20813132020488]
Ethylene Oxide
[20813132020488]
Ethylene Oxide
[20813132020488]
Ethylene Oxide
[20813132020488]
Ethylene Oxide
[20813132020488]
Ethylene Oxide
[20813132020488]
Ethylene Oxide
[20813132020488]
Ethylene Oxide
[20813132020488]
Ethylene Oxide
[20813132020488]
Ethylene Oxide
[20813132020488]
Ethylene Oxide
[20813132020488]
Ethylene Oxide
[20813132020488]
Ethylene Oxide
[20813132020488]
Ethylene Oxide
[20813132020488]
Ethylene Oxide
[20813132020488]
Ethylene Oxide
[20813132020488]
Ethylene Oxide
[20813132020488]
Ethylene Oxide
[20813132020488]
Ethylene Oxide
[20813132020488]
Ethylene Oxide
[20813132020488]
Ethylene Oxide
[20813132020488]
Ethylene Oxide
[20813132020488]
Ethylene Oxide
[20813132020488]
Ethylene Oxide
[20813132020488]
Ethylene Oxide
[20813132020488]
Ethylene Oxide
[20813132020488]
Ethylene Oxide
[20813132020488]
Ethylene Oxide
[20813132020488]
Ethylene Oxide
[20813132020488]
Ethylene Oxide
[20813132020488]
Ethylene Oxide
[20813132020488]
Ethylene Oxide
[20813132020488]
Ethylene Oxide
[20813132020488]
Ethylene Oxide
[20813132020488]
Ethylene Oxide
[20813132020488]
Ethylene Oxide
[20813132020488]
Ethylene Oxide
[20813132020488]
Ethylene Oxide
[20813132020488]
Ethylene Oxide
[20813132020488]
Ethylene Oxide
[20813132020488]
Ethylene Oxide
[20813132020488]
Ethylene Oxide
[20813132020488]
Ethylene Oxide
[20813132020488]
Ethylene Oxide
| Public Version Status | Update | 
| Device Record Status | Published | 
| Public Version Number | 4 | 
| Public Version Date | 2019-01-23 | 
| Device Publish Date | 2015-02-06 | 
| M204518093AB0 | Quick-Cross™Select Support Catheter | 
| M204518091AB0 | Quick-Cross™Select Support Catheter | 
| M204518089AB0 | Quick-Cross™Select Support Catheter | 
| M204518087AB0 | Quick-Cross™Select Support Catheter | 
| M204518085AB0 | Quick-Cross™Select Support Catheter | 
| M204518083AB0 | Quick-Cross™Select Support Catheter | 
| M204518081AB0 | Quick-Cross™Select Support Catheter | 
| M204518079AB0 | Quick-Cross™Select Support Catheter | 
| M204518077AB0 | Quick-Cross™Select Support Catheter | 
| 20813132020624 | Quick-Cross™Select Support Catheter | 
| 20813132020600 | Quick-Cross™Select Support Catheter | 
| 20813132020587 | Quick-Cross™Select Support Catheter | 
| 20813132020563 | Quick-Cross™Select Support Catheter | 
| 20813132020549 | Quick-Cross™Select Support Catheter | 
| 20813132020525 | Quick-Cross™Select Support Catheter | 
| 20813132020501 | Quick-Cross™Select Support Catheter | 
| 20813132020488 | Quick-Cross™Select Support Catheter | 
| 20813132020464 | Quick-Cross™Select Support Catheter | 
| M2045180931 | Quick-Cross™Select Support Catheter | 
| M2045180911 | Quick-Cross™Select Support Catheter | 
| M2045180891 | Quick-Cross™Select Support Catheter | 
| M2045180871 | Quick-Cross™Select Support Catheter | 
| M2045180851 | Quick-Cross™Select Support Catheter | 
| M2045180831 | Quick-Cross™Select Support Catheter | 
| M2045180811 | Quick-Cross™Select Support Catheter | 
| M2045180791 | Quick-Cross™Select Support Catheter | 
| M2045180771 | Quick-Cross™Select Support Catheter | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  QUICK-CROSS  78278418  2928706 Live/Registered | The Spectranetics Corporation 2003-07-24 |