| Primary Device ID | 00850007350390 |
| NIH Device Record Key | 3892e379-701f-406f-ab8f-6ffccaf7202e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Advance Salivary Duct Balloon Catheter Set - 1.5 |
| Version Model Number | SDBS-14-30-1.5-2 |
| 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 | 00850007350390 [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 |
| 00850007350321 - Wire Guide | 2026-02-18 |
| 00850007350338 - Salivary Access Dilator Set | 2026-02-18 |
| 00850007350345 - Kolenda Salivary Introducer Set - 5.0 | 2026-02-18 |
| 00850007350352 - Kolenda Salivary Introducer Set - 6.0 | 2026-02-18 |
| 00850007350369 - NGage Salivary Stone Extractor | 2026-02-18 |
| 00850007350376 - NCircle Tipless Salivary Stone Extractor | 2026-02-18 |
| 00850007350383 - Sialocath Salivary Duct Catheter | 2026-02-18 |
| 00850007350390 - Advance Salivary Duct Balloon Catheter Set - 1.5 | 2026-02-18 |
| 00850007350390 - Advance Salivary Duct Balloon Catheter Set - 1.5 | 2026-02-18 |