Disposable Platform Blades

GUDID 00899054002623

Disposable Platform Blades for Reusable Activator Drive

KDL MEDICAL, INC.

Sternum spreader Sternum spreader Sternum spreader Sternum spreader Sternum spreader Sternum spreader Sternum spreader Sternum spreader Sternum spreader Sternum spreader Sternum spreader Sternum spreader Sternum spreader Sternum spreader Sternum spreader Sternum spreader Sternum spreader
Primary Device ID00899054002623
NIH Device Record Keyb8a3efb9-5ef7-4423-9d68-dbed93426617
Commercial Distribution StatusIn Commercial Distribution
Brand NameDisposable Platform Blades
Version Model NumberDPB-8000S
Company DUNS791048924
Company NameKDL MEDICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone972-783-7005
Emailregulatory@chasemedical.com
Phone972-783-7005
Emailregulatory@chasemedical.com
Phone972-783-7005
Emailregulatory@chasemedical.com
Phone972-783-7005
Emailregulatory@chasemedical.com
Phone972-783-7005
Emailregulatory@chasemedical.com
Phone972-783-7005
Emailregulatory@chasemedical.com
Phone972-783-7005
Emailregulatory@chasemedical.com
Phone972-783-7005
Emailregulatory@chasemedical.com
Phone972-783-7005
Emailregulatory@chasemedical.com
Phone972-783-7005
Emailregulatory@chasemedical.com
Phone972-783-7005
Emailregulatory@chasemedical.com
Phone972-783-7005
Emailregulatory@chasemedical.com
Phone972-783-7005
Emailregulatory@chasemedical.com
Phone972-783-7005
Emailregulatory@chasemedical.com
Phone972-783-7005
Emailregulatory@chasemedical.com
Phone972-783-7005
Emailregulatory@chasemedical.com
Phone972-783-7005
Emailregulatory@chasemedical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100899054002623 [Primary]

FDA Product Code

DWSInstruments, Surgical, Cardiovascular

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-12-25
Device Publish Date2023-12-15

Devices Manufactured by KDL MEDICAL, INC.

00899054002753 - Sof-Flo Atraumatic Coronary Artery Shunt2024-05-06 Vessel Shunt 2.25mm Tapered Tip, 12mm Shaft
00899054002760 - Sof-Flo Atraumatic Coronary Artery Shunt2024-05-06 Vessel Shunt 2.25mm Tapered Tip, 12mm Shaft, ST
00899054002623 - Disposable Platform Blades2023-12-25Disposable Platform Blades for Reusable Activator Drive
00899054002623 - Disposable Platform Blades2023-12-25 Disposable Platform Blades for Reusable Activator Drive
00899054002289 - Foot Pedal, Single Valve2021-10-27 Single Foot Valve for Stabilizer with Blower
00899054002067 - Mannequin™ Endoventricular Shaper2020-05-06 Mannequin™ Endoventricular Shaper, 80cc
00899054002098 - Mannequin™ Endoventricular Shaper2020-05-06 Mannequin™ Endoventricular Shaper, 90cc
00899054002111 - Mannequin™ Endoventricular Shaper2020-05-06 Mannequin™ Endoventricular Shaper, 100cc
00899054002142 - Mannequin™ Endoventricular Shaper2020-05-06 Mannequin™ Endoventricular Shaper, 110cc

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.