| Primary Device ID | 00850007350321 |
| NIH Device Record Key | 3586fbd9-ec7c-4d1a-a1ad-a5efc6241b40 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Wire Guide |
| Version Model Number | C-SF-15-50 |
| 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 | 00850007350321 [Primary] |
| DQX | Wire, Guide, Catheter |
| 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 |
| 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 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() WIRE GUIDE 77803740 not registered Dead/Abandoned |
Nadco Tapes and Labels, Inc. 2009-08-13 |