| Primary Device ID | 00850007350406 |
| NIH Device Record Key | 6c6c4068-b39a-4cc6-a6c4-11463f741a65 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Advance Salivary Duct Balloon Catheter Set - 2.0 |
| Version Model Number | SDBS-14-30-2.0-2 |
| Company DUNS | 116981210 |
| Company Name | C2DX, INC. |
| 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 |
| Phone | 888-902-2239 |
| info@everismedical.com | |
| Phone | 888-902-2239 |
| info@everismedical.com | |
| Phone | 888-902-2239 |
| info@everismedical.com | |
| Phone | 888-902-2239 |
| info@everismedical.com | |
| Phone | 888-902-2239 |
| info@everismedical.com | |
| Phone | 888-902-2239 |
| info@everismedical.com | |
| Phone | 888-902-2239 |
| info@everismedical.com | |
| Phone | 888-902-2239 |
| info@everismedical.com | |
| Phone | 888-902-2239 |
| info@everismedical.com | |
| Phone | 888-902-2239 |
| info@everismedical.com | |
| Phone | 888-902-2239 |
| info@everismedical.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850007350406 [Primary] |
| GCJ | Laparoscope, General & Plastic Surgery |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-02-18 |
| Device Publish Date | 2026-02-10 |