| Primary Device ID | 00899054002623 |
| NIH Device Record Key | b8a3efb9-5ef7-4423-9d68-dbed93426617 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Disposable Platform Blades |
| Version Model Number | DPB-8000S |
| Company DUNS | 791048924 |
| Company Name | KDL MEDICAL, INC. |
| 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 | true |
| 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 | false |
| OTC Over-The-Counter | false |
| Phone | 972-783-7005 |
| regulatory@chasemedical.com | |
| Phone | 972-783-7005 |
| regulatory@chasemedical.com | |
| Phone | 972-783-7005 |
| regulatory@chasemedical.com | |
| Phone | 972-783-7005 |
| regulatory@chasemedical.com | |
| Phone | 972-783-7005 |
| regulatory@chasemedical.com | |
| Phone | 972-783-7005 |
| regulatory@chasemedical.com | |
| Phone | 972-783-7005 |
| regulatory@chasemedical.com | |
| Phone | 972-783-7005 |
| regulatory@chasemedical.com | |
| Phone | 972-783-7005 |
| regulatory@chasemedical.com | |
| Phone | 972-783-7005 |
| regulatory@chasemedical.com | |
| Phone | 972-783-7005 |
| regulatory@chasemedical.com | |
| Phone | 972-783-7005 |
| regulatory@chasemedical.com | |
| Phone | 972-783-7005 |
| regulatory@chasemedical.com | |
| Phone | 972-783-7005 |
| regulatory@chasemedical.com | |
| Phone | 972-783-7005 |
| regulatory@chasemedical.com | |
| Phone | 972-783-7005 |
| regulatory@chasemedical.com | |
| Phone | 972-783-7005 |
| regulatory@chasemedical.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00899054002623 [Primary] |
| DWS | Instruments, Surgical, Cardiovascular |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-12-25 |
| Device Publish Date | 2023-12-15 |
| 00899054002753 - Sof-Flo Atraumatic Coronary Artery Shunt | 2024-05-06 Vessel Shunt 2.25mm Tapered Tip, 12mm Shaft |
| 00899054002760 - Sof-Flo Atraumatic Coronary Artery Shunt | 2024-05-06 Vessel Shunt 2.25mm Tapered Tip, 12mm Shaft, ST |
| 00899054002623 - Disposable Platform Blades | 2023-12-25Disposable Platform Blades for Reusable Activator Drive |
| 00899054002623 - Disposable Platform Blades | 2023-12-25 Disposable Platform Blades for Reusable Activator Drive |
| 00899054002289 - Foot Pedal, Single Valve | 2021-10-27 Single Foot Valve for Stabilizer with Blower |
| 00899054002067 - Mannequin™ Endoventricular Shaper | 2020-05-06 Mannequin™ Endoventricular Shaper, 80cc |
| 00899054002098 - Mannequin™ Endoventricular Shaper | 2020-05-06 Mannequin™ Endoventricular Shaper, 90cc |
| 00899054002111 - Mannequin™ Endoventricular Shaper | 2020-05-06 Mannequin™ Endoventricular Shaper, 100cc |
| 00899054002142 - Mannequin™ Endoventricular Shaper | 2020-05-06 Mannequin™ Endoventricular Shaper, 110cc |