| Primary Device ID | 00857141005001 |
| NIH Device Record Key | 4ad33f4c-15a7-4e69-ade8-852343f28acc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OptionELITE Vena Cava Filter |
| Version Model Number | 352506070E |
| Catalog Number | 352506070E |
| Company DUNS | 079535216 |
| Company Name | Rex Medical LLP |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | MR Conditional |
| 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 | 800-927-4669 |
| Customer.Service@argonmedical.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00857141005001 [Primary] |
| DTK | Filter, Intravascular, 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 | 2018-03-29 |
| Device Publish Date | 2015-12-07 |
| 00857141005261 - Quadra-Fuse Multi-Pronged Injection Needle | 2020-12-15 |
| 00857141005278 - Quadra-Fuse Multi-Pronged Injection Needle | 2020-12-15 |
| 00857141005285 - Quadra-Fuse Multi-Pronged Injection Needle | 2020-12-15 |
| 00857141005292 - Quadra-Fuse Multi-Pronged Injection Needle | 2020-12-15 |
| 00857141005308 - Quadra-Fuse Multi-Pronged Injection Needle | 2020-12-15 |
| 00857141005315 - Quadra-Fuse Multi-Pronged Injection Needle | 2020-12-15 |
| 00857141005001 - OptionELITE Vena Cava Filter | 2018-03-29 |
| 00857141005001 - OptionELITE Vena Cava Filter | 2018-03-29 |
| 00857141005018 - OptionELITE Vena Cava Filter, 100cm | 2018-03-29 |