| Primary Device ID | 08886483507524 |
| NIH Device Record Key | 7e60f415-f7db-4f52-ae84-c063ab34b1be |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Embolectomy Catheter |
| Version Model Number | EL3340 |
| Catalog Number | EC-0001-003 |
| Company DUNS | 595182247 |
| Company Name | BIOPTIMAL INTERNATIONAL PTE. LTD. |
| 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 | true |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark cool dry places |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark cool dry places |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark cool dry places |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark cool dry places |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark cool dry places |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark cool dry places |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark cool dry places |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark cool dry places |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark cool dry places |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark cool dry places |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark cool dry places |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark cool dry places |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark cool dry places |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08886483507524 [Primary] |
| DXE | Catheter, Embolectomy |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-11-08 |
| Device Publish Date | 2023-10-31 |