| 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 |
| 00899054002647 - Cobra Surgical Arm, 16cm Length, Lg/Med/Sm Links, Shaft Connect | 2025-02-18 Cobra Surgical Arm, 16cm Length, Lg/Med/Sm Links, Shaft Connect |
| 00899054002654 - Cobra Surgical Arm, 19cm Length, Lg/Med/Sm Links, Shaft Connect | 2025-02-18 Cobra Surgical Arm, 19cm Length, Lg/Med/Sm Links, Shaft Connect Cobra Surgical Arm, 16cm Length, Lg/Med/Sm Links, Shaft Connect |
| 00899054002661 - Valve Assist Blade, Reusable, Stainless Steel, 11mm x 26mm | 2025-02-18 Valve Assist Blade, Reusable, Stainless Steel, 11mm x 26mm |
| 00899054002678 - Valve Assist Blade, Reusable, Stainless Steel, 15mm x 26mm | 2025-02-18 Valve Assist Blade, Reusable, Stainless Steel, 15mm x 26mm |
| 00899054002685 - Valve Assist Blade, Reusable, Stainless Steel, 18mm x 26mm | 2025-02-18 Valve Assist Blade, Reusable, Stainless Steel, 18mm x 26mm |
| 00899054002692 - Atrial Rake, Reusable, Stainless Steel, 19mm x 24mm | 2025-02-18 Atrial Rake, Reusable, Stainless Steel, 19mm x 24mm |
| 00899054002708 - Atrial Rake, Reusable, Stainless Steel, 19mm x 24mm, Knurled, Long | 2025-02-18 Atrial Rake, Reusable, Stainless Steel, 19mm x 24mm, Knurled, Long |
| 00899054002715 - Atrial Rake, Reusable, Stainless Steel, 29mm x 30mm | 2025-02-18 Atrial Rake, Reusable, Stainless Steel, 29mm x 30mm |