Tack Endovascular System (3.5-6.0mm) 156120061

GUDID 00863328000103

Sterile 6F System, 120cm

INTACT VASCULAR, INC.

Multiple peripheral artery stent, bare-metal
Primary Device ID00863328000103
NIH Device Record Keyeda2b4ea-2479-4acc-85c2-2705690ce16c
Commercial Distribution StatusIn Commercial Distribution
Brand NameTack Endovascular System (3.5-6.0mm)
Version Model Number6F
Catalog Number156120061
Company DUNS078732453
Company NameINTACT VASCULAR, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
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

Phone800-865-0214
Emailcs@intactvascular.com
Phone800-865-0214
Emailcs@intactvascular.com
Phone800-865-0214
Emailcs@intactvascular.com
Phone800-865-0214
Emailcs@intactvascular.com
Phone800-865-0214
Emailcs@intactvascular.com
Phone800-865-0214
Emailcs@intactvascular.com
Phone800-865-0214
Emailcs@intactvascular.com
Phone800-865-0214
Emailcs@intactvascular.com
Phone800-865-0214
Emailcs@intactvascular.com
Phone800-865-0214
Emailcs@intactvascular.com
Phone800-865-0214
Emailcs@intactvascular.com
Phone800-865-0214
Emailcs@intactvascular.com
Phone800-865-0214
Emailcs@intactvascular.com
Phone800-865-0214
Emailcs@intactvascular.com
Phone800-865-0214
Emailcs@intactvascular.com
Phone800-865-0214
Emailcs@intactvascular.com
Phone800-865-0214
Emailcs@intactvascular.com
Phone800-865-0214
Emailcs@intactvascular.com
Phone800-865-0214
Emailcs@intactvascular.com
Phone800-865-0214
Emailcs@intactvascular.com
Phone800-865-0214
Emailcs@intactvascular.com
Phone800-865-0214
Emailcs@intactvascular.com
Phone800-865-0214
Emailcs@intactvascular.com
Phone800-865-0214
Emailcs@intactvascular.com
Phone800-865-0214
Emailcs@intactvascular.com
Phone800-865-0214
Emailcs@intactvascular.com
Phone800-865-0214
Emailcs@intactvascular.com
Phone800-865-0214
Emailcs@intactvascular.com
Phone800-865-0214
Emailcs@intactvascular.com
Phone800-865-0214
Emailcs@intactvascular.com
Phone800-865-0214
Emailcs@intactvascular.com
Phone800-865-0214
Emailcs@intactvascular.com
Phone800-865-0214
Emailcs@intactvascular.com
Phone800-865-0214
Emailcs@intactvascular.com
Phone800-865-0214
Emailcs@intactvascular.com
Phone800-865-0214
Emailcs@intactvascular.com
Phone800-865-0214
Emailcs@intactvascular.com
Phone800-865-0214
Emailcs@intactvascular.com
Phone800-865-0214
Emailcs@intactvascular.com
Phone800-865-0214
Emailcs@intactvascular.com
Phone800-865-0214
Emailcs@intactvascular.com
Phone800-865-0214
Emailcs@intactvascular.com
Phone800-865-0214
Emailcs@intactvascular.com
Phone800-865-0214
Emailcs@intactvascular.com
Phone800-865-0214
Emailcs@intactvascular.com
Phone800-865-0214
Emailcs@intactvascular.com
Phone800-865-0214
Emailcs@intactvascular.com
Phone800-865-0214
Emailcs@intactvascular.com
Phone800-865-0214
Emailcs@intactvascular.com
Phone800-865-0214
Emailcs@intactvascular.com
Phone800-865-0214
Emailcs@intactvascular.com
Phone800-865-0214
Emailcs@intactvascular.com
Phone800-865-0214
Emailcs@intactvascular.com
Phone800-865-0214
Emailcs@intactvascular.com
Phone800-865-0214
Emailcs@intactvascular.com
Phone800-865-0214
Emailcs@intactvascular.com
Phone800-865-0214
Emailcs@intactvascular.com
Phone800-865-0214
Emailcs@intactvascular.com
Phone800-865-0214
Emailcs@intactvascular.com
Phone800-865-0214
Emailcs@intactvascular.com
Phone800-865-0214
Emailcs@intactvascular.com
Phone800-865-0214
Emailcs@intactvascular.com
Phone800-865-0214
Emailcs@intactvascular.com
Phone800-865-0214
Emailcs@intactvascular.com
Phone800-865-0214
Emailcs@intactvascular.com
Phone800-865-0214
Emailcs@intactvascular.com
Phone800-865-0214
Emailcs@intactvascular.com
Phone800-865-0214
Emailcs@intactvascular.com
Phone800-865-0214
Emailcs@intactvascular.com
Phone800-865-0214
Emailcs@intactvascular.com
Phone800-865-0214
Emailcs@intactvascular.com
Phone800-865-0214
Emailcs@intactvascular.com
Phone800-865-0214
Emailcs@intactvascular.com
Phone800-865-0214
Emailcs@intactvascular.com
Phone800-865-0214
Emailcs@intactvascular.com
Phone800-865-0214
Emailcs@intactvascular.com
Phone800-865-0214
Emailcs@intactvascular.com
Phone800-865-0214
Emailcs@intactvascular.com
Phone800-865-0214
Emailcs@intactvascular.com
Phone800-865-0214
Emailcs@intactvascular.com
Phone800-865-0214
Emailcs@intactvascular.com
Phone800-865-0214
Emailcs@intactvascular.com
Phone800-865-0214
Emailcs@intactvascular.com
Phone800-865-0214
Emailcs@intactvascular.com
Phone800-865-0214
Emailcs@intactvascular.com
Phone800-865-0214
Emailcs@intactvascular.com
Phone800-865-0214
Emailcs@intactvascular.com
Phone800-865-0214
Emailcs@intactvascular.com
Phone800-865-0214
Emailcs@intactvascular.com
Phone800-865-0214
Emailcs@intactvascular.com
Phone800-865-0214
Emailcs@intactvascular.com
Phone800-865-0214
Emailcs@intactvascular.com
Phone800-865-0214
Emailcs@intactvascular.com
Phone800-865-0214
Emailcs@intactvascular.com
Phone800-865-0214
Emailcs@intactvascular.com

Device Dimensions

Device Size Text, specify0
Catheter Working Length120 Centimeter
Catheter Inner Diameter0.035 Inch
Device Size Text, specify0
Device Size Text, specify0
Catheter Working Length120 Centimeter
Catheter Inner Diameter0.035 Inch
Device Size Text, specify0
Device Size Text, specify0
Catheter Working Length120 Centimeter
Catheter Inner Diameter0.035 Inch
Device Size Text, specify0
Device Size Text, specify0
Catheter Working Length120 Centimeter
Catheter Inner Diameter0.035 Inch
Device Size Text, specify0
Device Size Text, specify0
Catheter Working Length120 Centimeter
Catheter Inner Diameter0.035 Inch
Device Size Text, specify0
Device Size Text, specify0
Catheter Working Length120 Centimeter
Catheter Inner Diameter0.035 Inch
Device Size Text, specify0
Device Size Text, specify0
Catheter Working Length120 Centimeter
Catheter Inner Diameter0.035 Inch
Device Size Text, specify0
Device Size Text, specify0
Catheter Working Length120 Centimeter
Catheter Inner Diameter0.035 Inch
Device Size Text, specify0
Device Size Text, specify0
Catheter Working Length120 Centimeter
Catheter Inner Diameter0.035 Inch
Device Size Text, specify0
Device Size Text, specify0
Catheter Working Length120 Centimeter
Catheter Inner Diameter0.035 Inch
Device Size Text, specify0
Device Size Text, specify0
Catheter Working Length120 Centimeter
Catheter Inner Diameter0.035 Inch
Device Size Text, specify0
Device Size Text, specify0
Catheter Working Length120 Centimeter
Catheter Inner Diameter0.035 Inch
Device Size Text, specify0
Device Size Text, specify0
Catheter Working Length120 Centimeter
Catheter Inner Diameter0.035 Inch
Device Size Text, specify0
Device Size Text, specify0
Catheter Working Length120 Centimeter
Catheter Inner Diameter0.035 Inch
Device Size Text, specify0
Device Size Text, specify0
Catheter Working Length120 Centimeter
Catheter Inner Diameter0.035 Inch
Device Size Text, specify0
Device Size Text, specify0
Catheter Working Length120 Centimeter
Catheter Inner Diameter0.035 Inch
Device Size Text, specify0
Device Size Text, specify0
Catheter Working Length120 Centimeter
Catheter Inner Diameter0.035 Inch
Device Size Text, specify0
Device Size Text, specify0
Catheter Working Length120 Centimeter
Catheter Inner Diameter0.035 Inch
Device Size Text, specify0
Device Size Text, specify0
Catheter Working Length120 Centimeter
Catheter Inner Diameter0.035 Inch
Device Size Text, specify0
Device Size Text, specify0
Catheter Working Length120 Centimeter
Catheter Inner Diameter0.035 Inch
Device Size Text, specify0
Device Size Text, specify0
Catheter Working Length120 Centimeter
Catheter Inner Diameter0.035 Inch
Device Size Text, specify0
Device Size Text, specify0
Catheter Working Length120 Centimeter
Catheter Inner Diameter0.035 Inch
Device Size Text, specify0
Device Size Text, specify0
Catheter Working Length120 Centimeter
Catheter Inner Diameter0.035 Inch
Device Size Text, specify0
Device Size Text, specify0
Catheter Working Length120 Centimeter
Catheter Inner Diameter0.035 Inch
Device Size Text, specify0
Device Size Text, specify0
Catheter Working Length120 Centimeter
Catheter Inner Diameter0.035 Inch
Device Size Text, specify0
Device Size Text, specify0
Catheter Working Length120 Centimeter
Catheter Inner Diameter0.035 Inch
Device Size Text, specify0
Device Size Text, specify0
Catheter Working Length120 Centimeter
Catheter Inner Diameter0.035 Inch
Device Size Text, specify0
Device Size Text, specify0
Catheter Working Length120 Centimeter
Catheter Inner Diameter0.035 Inch
Device Size Text, specify0
Device Size Text, specify0
Catheter Working Length120 Centimeter
Catheter Inner Diameter0.035 Inch
Device Size Text, specify0
Device Size Text, specify0
Catheter Working Length120 Centimeter
Catheter Inner Diameter0.035 Inch
Device Size Text, specify0
Device Size Text, specify0
Catheter Working Length120 Centimeter
Catheter Inner Diameter0.035 Inch
Device Size Text, specify0
Device Size Text, specify0
Catheter Working Length120 Centimeter
Catheter Inner Diameter0.035 Inch
Device Size Text, specify0
Device Size Text, specify0
Catheter Working Length120 Centimeter
Catheter Inner Diameter0.035 Inch
Device Size Text, specify0
Device Size Text, specify0
Catheter Working Length120 Centimeter
Catheter Inner Diameter0.035 Inch
Device Size Text, specify0
Device Size Text, specify0
Catheter Working Length120 Centimeter
Catheter Inner Diameter0.035 Inch
Device Size Text, specify0
Device Size Text, specify0
Catheter Working Length120 Centimeter
Catheter Inner Diameter0.035 Inch
Device Size Text, specify0
Device Size Text, specify0
Catheter Working Length120 Centimeter
Catheter Inner Diameter0.035 Inch
Device Size Text, specify0
Device Size Text, specify0
Catheter Working Length120 Centimeter
Catheter Inner Diameter0.035 Inch
Device Size Text, specify0
Device Size Text, specify0
Catheter Working Length120 Centimeter
Catheter Inner Diameter0.035 Inch
Device Size Text, specify0
Device Size Text, specify0
Catheter Working Length120 Centimeter
Catheter Inner Diameter0.035 Inch
Device Size Text, specify0
Device Size Text, specify0
Catheter Working Length120 Centimeter
Catheter Inner Diameter0.035 Inch
Device Size Text, specify0
Device Size Text, specify0
Catheter Working Length120 Centimeter
Catheter Inner Diameter0.035 Inch
Device Size Text, specify0
Device Size Text, specify0
Catheter Working Length120 Centimeter
Catheter Inner Diameter0.035 Inch
Device Size Text, specify0
Device Size Text, specify0
Catheter Working Length120 Centimeter
Catheter Inner Diameter0.035 Inch
Device Size Text, specify0
Device Size Text, specify0
Catheter Working Length120 Centimeter
Catheter Inner Diameter0.035 Inch
Device Size Text, specify0
Device Size Text, specify0
Catheter Length120 Centimeter
Catheter Length120 Centimeter
Catheter Length120 Centimeter
Catheter Length120 Centimeter
Catheter Length120 Centimeter
Catheter Length120 Centimeter
Catheter Length120 Centimeter
Catheter Length120 Centimeter
Catheter Length120 Centimeter
Catheter Length120 Centimeter
Catheter Length120 Centimeter
Catheter Length120 Centimeter
Catheter Length120 Centimeter
Catheter Length120 Centimeter
Catheter Length120 Centimeter
Catheter Length120 Centimeter
Catheter Length120 Centimeter
Catheter Length120 Centimeter
Catheter Length120 Centimeter
Catheter Length120 Centimeter
Catheter Length120 Centimeter
Catheter Length120 Centimeter
Catheter Length120 Centimeter
Catheter Length120 Centimeter
Catheter Length120 Centimeter
Catheter Length120 Centimeter
Catheter Length120 Centimeter
Catheter Length120 Centimeter
Catheter Length120 Centimeter
Catheter Length120 Centimeter
Catheter Length120 Centimeter
Catheter Length120 Centimeter
Catheter Length120 Centimeter
Catheter Length120 Centimeter
Catheter Length120 Centimeter
Catheter Length120 Centimeter
Catheter Length120 Centimeter
Catheter Length120 Centimeter
Catheter Length120 Centimeter
Catheter Length120 Centimeter
Catheter Length120 Centimeter
Catheter Length120 Centimeter
Catheter Length120 Centimeter
Catheter Length120 Centimeter
Catheter Length120 Centimeter
Catheter Length120 Centimeter
Catheter Length120 Centimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight

Device Identifiers

Device Issuing AgencyDevice ID
GS100863328000103 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QCTScaffold, Dissection Repair

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-02-24
Device Publish Date2019-04-30

On-Brand Devices [Tack Endovascular System (3.5-6.0mm)]

00863328000103Sterile 6F System, 120cm
00863328000127Sterile 6F System, 135cm
00863328000110Sterile 6F System, 80cm

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