| Primary Device ID | 10724995231863 |
| NIH Device Record Key | 8f357892-36c2-4d1d-ae96-0dfbed0ca164 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ASCENDO submucosal lifting agent |
| Version Model Number | 00712935 |
| Company DUNS | 557812775 |
| Company Name | THE STANDARD CO.,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 | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00724995231866 [Primary] |
| GS1 | 10724995231863 [Package] Contains: 00724995231866 Package: paper box [5 Units] Discontinued: 2024-09-02 Not in Commercial Distribution |
| GS1 | 50724995231861 [Package] Package: Carton box [12 Units] Discontinued: 2024-09-02 Not in Commercial Distribution |
| PLL | Submucosal Injection Agent |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-09-10 |
| Device Publish Date | 2024-09-02 |