| Primary Device ID | 16941513203605 |
| NIH Device Record Key | bf0105f0-ff25-4b30-90fa-4792a35f3fe1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | VedDilator; 3-Stage Balloon Dilation Catheter |
| Version Model Number | VDK-TBD-15/16.5/18-60-180 |
| Company DUNS | 544430136 |
| Company Name | Jiangsu Vedkang Medical Science and 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 | 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 | 06941513203608 [Primary] |
| GS1 | 16941513203605 [Package] Contains: 06941513203608 Package: BOX [1 Units] In Commercial Distribution |
| GS1 | 56941513203603 [Package] Package: carton [10 Units] In Commercial Distribution |
| KNQ | Dilator, Esophageal |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-08-28 |
| Device Publish Date | 2024-08-20 |
| 16941513203735 | VDK-TBD-18/19/20-80-180 |
| 16941513203711 | VDK-TBD-18/19/20-60-230 |
| 16941513203674 | VDK-TBD-15/16.5/18-80-230 |
| 16941513203667 | VDK-TBD-15/16.5/18-80-200 |
| 16941513203650 | VDK-TBD-15/16.5/18-80-180 |
| 16941513203643 | VDK-TBD-15/16.5/18-80-120 |
| 16941513203636 | VDK-TBD-15/16.5/18-80-90 |
| 16941513203629 | VDK-TBD-15/16.5/18-60-230 |
| 16941513203612 | VDK-TBD-15/16.5/18-60-200 |
| 16941513203605 | VDK-TBD-15/16.5/18-60-180 |
| 16941513203599 | VDK-TBD-15/16.5/18-60-120 |
| 16941513203582 | VDK-TBD-15/16.5/18-60-90 |