| Primary Device ID | 08809254454278 |
| NIH Device Record Key | fd189097-ab08-45ad-b32d-bb777158d78a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Well-Prep |
| Version Model Number | WE101-S000 |
| Company DUNS | 689698269 |
| Company Name | VERICOM CO., LTD. |
| Device Count | 1 |
| 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 | false |
| 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 | true |
| OTC Over-The-Counter | false |
| Phone | +82314412881 |
| vericom@vericom.co.kr |
| Storage Environment Temperature | Between 10 Degrees Celsius and 27 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08809254454278 [Primary] |
| EKQ | Preparer, Root Canal Endodontic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-02-27 |
| Device Publish Date | 2020-02-19 |
| 08809254454278 | EDTA Root Canal Preparation Cream-Cleanser, Endodontic, Root Canal; Well-Prep 1g X 1syringe |
| 08809254452199 | EDTA Root Canal Preparation Cream-Cleanser, Endodontic, Root Canal; Well-Prep 6g X 1syringe |