Heart Assist, Single Use, 2 Finger Long, Malleable 36mm W X 90mm L

GUDID 10899054002835

Heart Assist, Single Use, 2 Finger Long, Malleable 36mm W X 90mm L

KDL MEDICAL, INC.

Surgical instrument assist arm system, manually-adjusted
Primary Device ID10899054002835
NIH Device Record Keyf8724b7f-cfd3-4640-a470-650851f1d85a
Commercial Distribution StatusIn Commercial Distribution
Brand NameHeart Assist, Single Use, 2 Finger Long, Malleable 36mm W X 90mm L
Version Model NumberHAF-2LGS
Company DUNS791048924
Company NameKDL MEDICAL, INC.
Device Count5
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100899054002838 [Primary]
GS110899054002835 [Unit of Use]

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 Date2025-02-18
Device Publish Date2025-02-10

Devices Manufactured by KDL MEDICAL, INC.

00899054002647 - Cobra Surgical Arm, 16cm Length, Lg/Med/Sm Links, Shaft Connect2025-02-18 Cobra Surgical Arm, 16cm Length, Lg/Med/Sm Links, Shaft Connect
00899054002654 - Cobra Surgical Arm, 19cm Length, Lg/Med/Sm Links, Shaft Connect2025-02-18 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 26mm2025-02-18 Valve Assist Blade, Reusable, Stainless Steel, 11mm x 26mm
00899054002678 - Valve Assist Blade, Reusable, Stainless Steel, 15mm x 26mm2025-02-18 Valve Assist Blade, Reusable, Stainless Steel, 15mm x 26mm
00899054002685 - Valve Assist Blade, Reusable, Stainless Steel, 18mm x 26mm2025-02-18 Valve Assist Blade, Reusable, Stainless Steel, 18mm x 26mm
00899054002692 - Atrial Rake, Reusable, Stainless Steel, 19mm x 24mm2025-02-18 Atrial Rake, Reusable, Stainless Steel, 19mm x 24mm
00899054002708 - Atrial Rake, Reusable, Stainless Steel, 19mm x 24mm, Knurled, Long2025-02-18 Atrial Rake, Reusable, Stainless Steel, 19mm x 24mm, Knurled, Long
00899054002715 - Atrial Rake, Reusable, Stainless Steel, 29mm x 30mm2025-02-18 Atrial Rake, Reusable, Stainless Steel, 29mm x 30mm
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.