| Primary Device ID | 16975339627598 |
| NIH Device Record Key | 2f358e49-156f-4853-88e5-00ea26a40699 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CoralWell |
| Version Model Number | NS-0855B |
| Company DUNS | 723490133 |
| Company Name | MacroLux Medical Technology 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 | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06975339627591 [Primary] |
| GS1 | 16975339627598 [Package] Contains: 06975339627591 Package: Color box [1 Units] In Commercial Distribution |
| GS1 | 26975339627595 [Package] Package: Carton [10 Units] In Commercial Distribution |
| FED | Endoscopic Access Overtube, Gastroenterology-Urology |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-08-18 |
| Device Publish Date | 2025-08-10 |