| Primary Device ID | 10884450544102 |
| NIH Device Record Key | 8f563d71-96a6-467f-bef7-1e6091f5dc12 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Transvalvular Insertion Tool (TVI) |
| Version Model Number | 00884450544105 |
| Catalog Number | TVI-07 |
| Company DUNS | 184763290 |
| Company Name | Merit Medical Systems, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00884450544105 [Primary] |
| GS1 | 10884450544102 [Package] Contains: 00884450544105 Package: [5 Units] In Commercial Distribution |
| DWS | INSTRUMENTS, SURGICAL, CARDIOVASCULAR |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2024-03-20 |
| Device Publish Date | 2021-05-28 |
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