| Primary Device ID | 00815686021283 |
| NIH Device Record Key | 0fdda593-9d06-418d-8e46-2fa810d08a13 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SPiN Access Catheter, 180 Degree Catheter |
| Version Model Number | INS-5912 |
| Catalog Number | INS-5912 |
| Company DUNS | 181714804 |
| Company Name | VERAN MEDICAL TECHNOLOGIES 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 | true |
| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 00815686021283 [Primary] |
| JAK | System, X-Ray, Tomography, Computed |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-02-25 |
| Device Publish Date | 2021-02-17 |
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| 00815686021320 - SPiN Vision Video Processor | 2023-02-20 |
| 10815686021174 - SPiN Access Catheter, 90 Degree Catheter | 2021-02-25 |
| 10815686021181 - SPiN Access Catheter Always-On Tip Tracked Guidewire | 2021-02-25 |
| 10815686021273 - SPiN Access Catheter, 90 Degrees For Use With Olympus 190 Scopes | 2021-02-25 |
| 00815686021283 - SPiN Access Catheter, 180 Degree Catheter | 2021-02-25 |
| 00815686021283 - SPiN Access Catheter, 180 Degree Catheter | 2021-02-25 |
| 10815686021297 - SPiN Access Catheter, 180 Degrees For Use With Olympus 190 Scopes | 2021-02-25 |