| Primary Device ID | 26974843120110 |
| NIH Device Record Key | 8b96e00d-4416-4589-9636-3592ae892135 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CanalPro Color Syringes |
| Version Model Number | CanalPro Color Syringes (10 ml) blue |
| Company DUNS | 710958353 |
| Company Name | ZOGEAR Medical Co., Ltd. |
| Device Count | 50 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | 06974843120116 [Unit of Use] |
| GS1 | 16974843120113 [Primary] |
| GS1 | 26974843120110 [Package] Contains: 16974843120113 Package: carton [12 Units] In Commercial Distribution |
| EIC | Syringe, Periodontic, Endodontic, Irrigating |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-04-28 |
| Device Publish Date | 2023-04-20 |
| 26974843120172 | CanalPro Color Syringes (5 ml) white |
| 26974843120165 | CanalPro Color Syringes (5 ml) yellow |
| 26974843120158 | CanalPro Color Syringes (5 ml) blue |
| 26974843120141 | CanalPro Color Syringes (5 ml) red |
| 26974843120134 | CanalPro Color Syringes (10 ml) white |
| 26974843120127 | CanalPro Color Syringes (10 ml) yellow |
| 26974843120110 | CanalPro Color Syringes (10 ml) blue |
| 26974843120103 | CanalPro Color Syringes (10 ml) red |