Heart Assist, Single Use, 3 Finger Short, Malleable 60mm W X 54mm L

GUDID 10899054002842

Heart Assist, Single Use, 3 Finger Short, Malleable 60mm W X 54mm L

KDL MEDICAL, INC.

Surgical instrument assist arm system, manually-adjusted
Primary Device ID10899054002842
NIH Device Record Key5f0ef2d7-60f5-4782-bcbc-48b1915ec5d2
Commercial Distribution StatusIn Commercial Distribution
Brand NameHeart Assist, Single Use, 3 Finger Short, Malleable 60mm W X 54mm L
Version Model NumberHAF-3SHS
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
GS100899054002845 [Primary]
GS110899054002842 [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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