| Primary Device ID | 10852528005428 |
| NIH Device Record Key | 1767bc5f-d535-49d2-a583-473bca723fee |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Diamondback Coroanry |
| Version Model Number | DBEC-125 |
| Catalog Number | 70058-12 |
| 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 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
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| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10852528005428 [Primary] |
| MCX | Catheter, Coronary, Atherectomy |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[10852528005428]
Ethylene Oxide
[10852528005428]
Ethylene Oxide
[10852528005428]
Ethylene Oxide
[10852528005428]
Ethylene Oxide
[10852528005428]
Ethylene Oxide
[10852528005428]
Ethylene Oxide
[10852528005428]
Ethylene Oxide
[10852528005428]
Ethylene Oxide
[10852528005428]
Ethylene Oxide
[10852528005428]
Ethylene Oxide
[10852528005428]
Ethylene Oxide
[10852528005428]
Ethylene Oxide
[10852528005428]
Ethylene Oxide
[10852528005428]
Ethylene Oxide
[10852528005428]
Ethylene Oxide
[10852528005428]
Ethylene Oxide
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2023-12-18 |
| Device Publish Date | 2017-11-02 |
| 10852528005206 - Diamondback Peripheral | 2025-06-19 DIAMONDBACK PERIPHERAL, MICRO CROWN, 1.25MM, 60CM SHAFT |
| 10852528005213 - Diamondback Peripheral | 2025-06-19 DIAMONDBACK PERIPHERAL, SOLID CROWN, 1.25MM, 60CM SHAFT |
| 10852528005237 - Diamondback Peripheral | 2025-06-19 DIAMONDBACK PERIPHERAL, SOLID CROWN, 1.50MM, 145CM SHAFT |
| 10852528005244 - Diamondback Peripheral | 2025-06-19 DIAMONDBACK PERIPHERAL, SOLID CROWN, 1.25MM, 145CM SHAFT |
| 10852528005251 - Diamondback Peripheral | 2025-06-19 DIAMONDBACK PERIPHERAL, CLASSIC CROWN, 1.50MM, 145CM SHAFT |
| 10852528005268 - Diamondback Peripheral | 2025-06-19 DIAMONDBACK PERIPHERAL, CLASSIC CROWN, 2.00MM, 145CM SHAFT |
| 10852528005282 - Diamondback Peripheral | 2025-06-19 DIAMONDBACK PERIPHERAL, MICRO CROWN, 1.25MM, 145CM SHAFT |
| 10852528005350 - Diamondback Peripheral | 2025-06-17 Diamondback Peripheral, Radial Access OAD, 1.25mm, 10mm, 200cm shaft |