| Primary Device ID | 00850007350208 |
| NIH Device Record Key | d864d965-1bd6-4fda-9600-5553724590fa |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HEMOSTATIX THERMAL SCALPEL SYSTEM |
| Version Model Number | 7013-8400 |
| 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 | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| 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 |
| SALES@C2DX.COM | |
| Phone | 888-902-2239 |
| SALES@C2DX.COM | |
| Phone | 888-902-2239 |
| SALES@C2DX.COM | |
| Phone | 888-902-2239 |
| SALES@C2DX.COM | |
| Phone | 888-902-2239 |
| SALES@C2DX.COM | |
| Phone | 888-902-2239 |
| SALES@C2DX.COM | |
| Phone | 888-902-2239 |
| SALES@C2DX.COM | |
| Phone | 888-902-2239 |
| SALES@C2DX.COM | |
| Phone | 888-902-2239 |
| SALES@C2DX.COM | |
| Phone | 888-902-2239 |
| SALES@C2DX.COM | |
| Phone | 888-902-2239 |
| SALES@C2DX.COM | |
| Phone | 888-902-2239 |
| SALES@C2DX.COM | |
| Phone | 888-902-2239 |
| SALES@C2DX.COM | |
| Phone | 888-902-2239 |
| SALES@C2DX.COM | |
| Phone | 888-902-2239 |
| SALES@C2DX.COM | |
| Phone | 888-902-2239 |
| SALES@C2DX.COM | |
| Phone | 888-902-2239 |
| SALES@C2DX.COM |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850007350208 [Primary] |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-12-28 |
| Device Publish Date | 2023-12-20 |
| 00850007350208 - HEMOSTATIX THERMAL SCALPEL SYSTEM | 2023-12-28MODEL P8400 CONSOLE - QTY 1 |
| 00850007350208 - HEMOSTATIX THERMAL SCALPEL SYSTEM | 2023-12-28 MODEL P8400 CONSOLE - QTY 1 |
| 00850007350222 - SHAW SCALPEL | 2023-12-28 FOOTSWITCH FOR P8400 CONSOLE |
| 10850007350236 - SHAW SCALPEL | 2023-12-28 MODEL 8050 HANDLE - QTY 1 |
| 10850007350250 - SHAW SCALPEL | 2023-12-28 MODEL 9050 HANDLE - QTY 1 |
| 00850007350260 - SHAW SCALPEL | 2023-12-28 MODEL 5712 BLADE - QTY 10 |
| 00850007350215 - SHAW SCALPEL | 2023-12-28 MODEL 5710 BLADE - QTY 24 |
| 00850007350253 - SHAW SCALPEL | 2023-12-28 MODEL 9050 HANDLE - QTY 6 |
| 00850007350277 - SHAW SCALPEL | 2023-12-28 MODEL 5715 BLADE - QTY 24 |