Tack Endovascular System (4.0-8.0mm) 206080061

GUDID 00850003494050

Sterile 6F System, 80cm

INTACT VASCULAR, INC.

Multiple peripheral artery stent, bare-metal Multiple peripheral artery stent, bare-metal Multiple peripheral artery stent, bare-metal Multiple peripheral artery stent, bare-metal Multiple peripheral artery stent, bare-metal Multiple peripheral artery stent, bare-metal Multiple peripheral artery stent, bare-metal Multiple peripheral artery stent, bare-metal Multiple peripheral artery stent, bare-metal Multiple peripheral artery stent, bare-metal Multiple peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal
Primary Device ID00850003494050
NIH Device Record Key3883d2b6-12ce-4016-93a6-d6cbe6d86c70
Commercial Distribution StatusIn Commercial Distribution
Brand NameTack Endovascular System (4.0-8.0mm)
Version Model Number6F
Catalog Number206080061
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

Device Dimensions

Catheter Working Length80 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Catheter Inner Diameter0.035 Inch
Catheter Working Length80 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Catheter Inner Diameter0.035 Inch
Catheter Working Length80 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Catheter Inner Diameter0.035 Inch
Catheter Working Length80 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Catheter Inner Diameter0.035 Inch
Catheter Working Length80 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Catheter Inner Diameter0.035 Inch
Catheter Working Length80 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Catheter Inner Diameter0.035 Inch
Catheter Working Length80 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Catheter Inner Diameter0.035 Inch
Catheter Working Length80 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Catheter Inner Diameter0.035 Inch
Catheter Working Length80 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Catheter Inner Diameter0.035 Inch
Catheter Working Length80 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Catheter Inner Diameter0.035 Inch
Catheter Working Length80 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Catheter Inner Diameter0.035 Inch
Catheter Working Length80 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Catheter Inner Diameter0.035 Inch
Catheter Working Length80 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Catheter Inner Diameter0.035 Inch
Catheter Working Length80 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Catheter Inner Diameter0.035 Inch
Catheter Working Length80 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Catheter Inner Diameter0.035 Inch
Catheter Working Length80 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Catheter Inner Diameter0.035 Inch
Catheter Working Length80 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Catheter Inner Diameter0.035 Inch
Catheter Working Length80 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Catheter Inner Diameter0.035 Inch
Catheter Working Length80 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Catheter Inner Diameter0.035 Inch
Catheter Working Length80 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Catheter Inner Diameter0.035 Inch
Catheter Working Length80 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Catheter Inner Diameter0.035 Inch
Catheter Working Length80 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Catheter Inner Diameter0.035 Inch
Catheter Working Length80 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Catheter Inner Diameter0.035 Inch
Catheter Working Length80 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Catheter Inner Diameter0.035 Inch
Catheter Working Length80 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Catheter Inner Diameter0.035 Inch
Catheter Working Length80 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Catheter Inner Diameter0.035 Inch
Catheter Working Length80 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Catheter Inner Diameter0.035 Inch
Catheter Working Length80 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Catheter Inner Diameter0.035 Inch
Catheter Working Length80 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Catheter Inner Diameter0.035 Inch
Catheter Working Length80 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Catheter Inner Diameter0.035 Inch
Catheter Working Length80 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Catheter Inner Diameter0.035 Inch
Catheter Working Length80 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Catheter Inner Diameter0.035 Inch
Catheter Working Length80 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Catheter Inner Diameter0.035 Inch
Catheter Working Length80 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Catheter Inner Diameter0.035 Inch
Catheter Working Length80 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Catheter Inner Diameter0.035 Inch
Catheter Working Length80 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Catheter Inner Diameter0.035 Inch
Catheter Working Length80 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Catheter Inner Diameter0.035 Inch
Catheter Working Length80 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Catheter Inner Diameter0.035 Inch
Catheter Working Length80 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Catheter Inner Diameter0.035 Inch
Catheter Working Length80 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Catheter Inner Diameter0.035 Inch
Catheter Working Length80 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Catheter Inner Diameter0.035 Inch
Catheter Working Length80 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Catheter Inner Diameter0.035 Inch
Catheter Working Length80 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Catheter Inner Diameter0.035 Inch
Catheter Working Length80 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Catheter Inner Diameter0.035 Inch
Catheter Working Length80 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Catheter Inner Diameter0.035 Inch
Catheter Working Length80 Centimeter
Catheter Length80 Centimeter
Catheter Length80 Centimeter
Catheter Length80 Centimeter
Catheter Length80 Centimeter
Catheter Length80 Centimeter
Catheter Length80 Centimeter
Catheter Length80 Centimeter
Catheter Length80 Centimeter
Catheter Length80 Centimeter
Catheter Length80 Centimeter
Catheter Length80 Centimeter
Catheter Length80 Centimeter
Catheter Length80 Centimeter
Catheter Length80 Centimeter
Catheter Length80 Centimeter
Catheter Length80 Centimeter
Catheter Length80 Centimeter
Catheter Length80 Centimeter
Catheter Length80 Centimeter
Catheter Length80 Centimeter
Catheter Length80 Centimeter
Catheter Length80 Centimeter
Catheter Length80 Centimeter
Catheter Length80 Centimeter
Catheter Length80 Centimeter
Catheter Length80 Centimeter
Catheter Length80 Centimeter
Catheter Length80 Centimeter
Catheter Length80 Centimeter
Catheter Length80 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

Device Identifiers

Device Issuing AgencyDevice ID
GS100850003494050 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-03-02
Device Publish Date2020-02-22

On-Brand Devices [Tack Endovascular System (4.0-8.0mm)]

00850003494050Sterile 6F System, 80cm
00850003494043Sterile 6F System, 120cm
00850003494036Sterile 6F System, 135cm

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