Heart Assist, Single Use, 2 Finger Short, Malleable 36mm W X 54mm L

GUDID 10899054002828

Heart Assist, Single Use, 2 Finger Short, Malleable 36mm W X 54mm L

KDL MEDICAL, INC.

Surgical instrument assist arm system, manually-adjusted
Primary Device ID10899054002828
NIH Device Record Key9db6fc44-ecb4-4968-860b-482932285404
Commercial Distribution StatusIn Commercial Distribution
Brand NameHeart Assist, Single Use, 2 Finger Short, Malleable 36mm W X 54mm L
Version Model NumberHAF-2SHS
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
GS100899054002821 [Primary]
GS110899054002828 [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

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