| Primary Device ID | 10850000491356 |
| NIH Device Record Key | f3fb9ea9-110b-4806-9ded-1eec62e2f121 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Diamondback Coronary |
| Version Model Number | DBEC-125 |
| Catalog Number | 7-10060-01 |
| Company DUNS | 024954518 |
| Company Name | Cardiovascular Systems, Inc. |
| 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 | 651-259-1600 |
| customerservice@csi360.com | |
| Phone | 651-259-1600 |
| customerservice@csi360.com | |
| Phone | 651-259-1600 |
| customerservice@csi360.com | |
| Phone | 651-259-1600 |
| customerservice@csi360.com | |
| Phone | 651-259-1600 |
| customerservice@csi360.com | |
| Phone | 651-259-1600 |
| customerservice@csi360.com | |
| Phone | 651-259-1600 |
| customerservice@csi360.com | |
| Phone | 651-259-1600 |
| customerservice@csi360.com | |
| Phone | 651-259-1600 |
| customerservice@csi360.com | |
| Phone | 651-259-1600 |
| customerservice@csi360.com | |
| Phone | 651-259-1600 |
| customerservice@csi360.com | |
| Phone | 651-259-1600 |
| customerservice@csi360.com | |
| Phone | 651-259-1600 |
| customerservice@csi360.com | |
| Phone | 651-259-1600 |
| customerservice@csi360.com | |
| Phone | 651-259-1600 |
| customerservice@csi360.com | |
| Phone | 651-259-1600 |
| customerservice@csi360.com | |
| Phone | 651-259-1600 |
| customerservice@csi360.com |
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| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10850000491356 [Primary] |
| MCX | Catheter, Coronary, Atherectomy |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[10850000491356]
Ethylene Oxide
[10850000491356]
Ethylene Oxide
[10850000491356]
Ethylene Oxide
[10850000491356]
Ethylene Oxide
[10850000491356]
Ethylene Oxide
[10850000491356]
Ethylene Oxide
[10850000491356]
Ethylene Oxide
[10850000491356]
Ethylene Oxide
[10850000491356]
Ethylene Oxide
[10850000491356]
Ethylene Oxide
[10850000491356]
Ethylene Oxide
[10850000491356]
Ethylene Oxide
[10850000491356]
Ethylene Oxide
[10850000491356]
Ethylene Oxide
[10850000491356]
Ethylene Oxide
[10850000491356]
Ethylene Oxide
[10850000491356]
Ethylene Oxide
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-03-13 |
| Device Publish Date | 2020-03-05 |
| 30852528005705 | Guidewire, Viperwire Advance Coronary Flex Tip .014: dia, .012" 1 Pack 325 cm |
| 10850000491363 | DIAMONDBACK CORONARY, CLASSIC CROWN, 1.25MM, 135CM SHAFT |
| 10850000491356 | DIAMONDBACK CORONARY, CLASSIC CROWN, 1.25MM, 135CM SHAFT |
| 10850026568100 | DIAMONDBACK CORONARY, CLASSIC CROWN, 1.25MM, 135CM SHAFT |
| 10850026568087 | DIAMONDBACK CORONARY, CLASSIC CROWN, 1.25MM, 135CM SHAFT |
| 10850026568698 | DIAMONDBACK CORONARY, CLASSIC CROWN, 1.25MM, 135CM SHAFT |
| 10852528005442 | SALINE INFUSION PUMP (SIP) |
| 10852528005800 | SALINE INFUSION PUMP (SIP) |
| 10852528005787 | CORONARY ELECTRIC, CLASSIC CROWN, 1.25MM |
| 10852528005336 | DIAMONDBACK 360® Coronary Orbital Atherectomy System, Micro Crown |
| 30852528005187 | Guidewire, Viperwire Adavnce Coronary Floppy, .012: dia, .014" Spring Tip, 1 Pack 325 cm |
| 10852528005176 | CORONARY ELECTRIC, CLASSIC CROWN, 1.50MM |
| 10852528005169 | DIAMONDBACK CORONARY, CLASSIC CROWN, 1.25MM |