| Primary Device ID | 00850029546184 |
| NIH Device Record Key | 965b002e-2187-4133-b412-065f291003e3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | WOLF Thrombectomy System, 6F |
| Version Model Number | FD0427-02 |
| Company DUNS | 117672411 |
| Company Name | Devoro Medical 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 | false |
| OTC Over-The-Counter | false |
| Length | 25 Centimeter |
| Length | 25 Centimeter |
| Length | 25 Centimeter |
| Length | 25 Centimeter |
| Length | 25 Centimeter |
| Length | 25 Centimeter |
| Length | 25 Centimeter |
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| Length | 25 Centimeter |
| Length | 25 Centimeter |
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| Length | 25 Centimeter |
| Length | 25 Centimeter |
| Length | 25 Centimeter |
| Length | 25 Centimeter |
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| Length | 25 Centimeter |
| Length | 25 Centimeter |
| Length | 25 Centimeter |
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| Length | 25 Centimeter |
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| Length | 25 Centimeter |
| Length | 25 Centimeter |
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| Length | 25 Centimeter |
| Length | 25 Centimeter |
| Length | 25 Centimeter |
| Length | 25 Centimeter |
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| Length | 25 Centimeter |
| Length | 25 Centimeter |
| Length | 25 Centimeter |
| Length | 25 Centimeter |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850029546184 [Primary] |
| QEW | Peripheral Mechanical Thrombectomy With Aspiration |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-10-20 |
| Device Publish Date | 2022-10-12 |
| 00191506050016 - SmartClaw™ | 2024-06-13 Thrombectomy Catheter |
| 00191506050023 - SmartClaw™ | 2024-06-13 Thrombectomy Catheter |
| 00850029546009 - WOLF Thrombectomy SmartClaw Catheter | 2023-07-20 WOLF Thrombectomy SmartClaw Catheter, 20mm |
| 00850029546023 - WOLF Thrombectomy System, 14F | 2023-07-20 WOLF Thrombectomy System, 14F - 6mm Funnel x 110cm |
| 00850029546030 - WOLF Thrombectomy System, 14F | 2023-07-20 WOLF Thrombectomy System, 14F - 8mm Funnel x 110cm |
| 00850029546047 - WOLF Thrombectomy System, 14F | 2023-07-20 WOLF Thrombectomy System, 14F - 10mm Funnel x 110cm |
| 00850029546054 - WOLF Thrombectomy System, 14F | 2023-07-20 WOLF Thrombectomy System, 14F - 12mm Funnel x 110cm |
| 00850029546115 - WOLF Thrombectomy Reload Pack, 14F | 2023-07-20 WOLF Thrombectomy Reload Pack, 14F - 110cm |