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 |