Sof-Flo Atraumatic Coronary Artery Shunt

GUDID 00899054002555

Vessel Shunt 1.00mm Tapered Tip, 12mm Shaft, ST

KDL MEDICAL, INC.

Surgical intravascular shunt
Primary Device ID00899054002555
NIH Device Record Keyacc622d5-8725-48dc-92a0-416812c84329
Commercial Distribution StatusIn Commercial Distribution
Brand NameSof-Flo Atraumatic Coronary Artery Shunt
Version Model NumberSHT-1210S-C01
Company DUNS791048924
Company NameKDL MEDICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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
Emailcust_svc@chasemedical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100899054002555 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-05-02
Device Publish Date2019-04-24

On-Brand Devices [Sof-Flo Atraumatic Coronary Artery Shunt]

00899054002609Vessel Shunt 2.50mm Tapered Tip, 12mm Shaft, ST
00899054002593Vessel Shunt 2.00mm Tapered Tip, 12mm Shaft, ST
00899054002586Vessel Shunt 1.75mm Tapered Tip, 12mm Shaft, ST
00899054002579Vessel Shunt 1.50mm Tapered Tip, 12mm Shaft, ST
00899054002562Vessel Shunt 1.25mm Tapered Tip, 12mm Shaft, ST
00899054002555Vessel Shunt 1.00mm Tapered Tip, 12mm Shaft, ST
00899054002760Vessel Shunt 2.25mm Tapered Tip, 12mm Shaft, ST
00899054002753Vessel Shunt 2.25mm Tapered Tip, 12mm Shaft

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