Speed-Torque®

GUDID 10860003987350

Speed-Torque® Device Pouch

Vascugenix, LLC

Vascular guide-catheter, single-use
Primary Device ID10860003987350
NIH Device Record Key288f5ca2-c23c-4db3-afb6-ad58bce0300a
Commercial Distribution StatusIn Commercial Distribution
Brand NameSpeed-Torque®
Version Model NumberVSXT001
Company DUNS117166275
Company NameVascugenix, LLC
Device Count1
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 Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone5015008025
Emailinfo@vascugenix.com
Phone5015008025
Emailinfo@vascugenix.com
Phone5015008025
Emailinfo@vascugenix.com
Phone5015008025
Emailinfo@vascugenix.com
Phone5015008025
Emailinfo@vascugenix.com
Phone5015008025
Emailinfo@vascugenix.com
Phone5015008025
Emailinfo@vascugenix.com
Phone5015008025
Emailinfo@vascugenix.com
Phone5015008025
Emailinfo@vascugenix.com
Phone5015008025
Emailinfo@vascugenix.com
Phone5015008025
Emailinfo@vascugenix.com
Phone5015008025
Emailinfo@vascugenix.com
Phone5015008025
Emailinfo@vascugenix.com
Phone5015008025
Emailinfo@vascugenix.com
Phone5015008025
Emailinfo@vascugenix.com
Phone5015008025
Emailinfo@vascugenix.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100860003987353 [Primary]
GS110860003987350 [Package]
Contains: 00860003987353
Package: Box [10 Units]
In Commercial Distribution
GS120860003987357 [Package]
Package: Case [4 Units]
In Commercial Distribution

FDA Product Code

PTLWire, Guide, Catheter, Exempt

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[10860003987350]

Radiation Sterilization


[10860003987350]

Radiation Sterilization


[10860003987350]

Radiation Sterilization


[10860003987350]

Radiation Sterilization


[10860003987350]

Radiation Sterilization


[10860003987350]

Radiation Sterilization


[10860003987350]

Radiation Sterilization


[10860003987350]

Radiation Sterilization


[10860003987350]

Radiation Sterilization


[10860003987350]

Radiation Sterilization


[10860003987350]

Radiation Sterilization


[10860003987350]

Radiation Sterilization


[10860003987350]

Radiation Sterilization


[10860003987350]

Radiation Sterilization


[10860003987350]

Radiation Sterilization


[10860003987350]

Radiation Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-11-11
Device Publish Date2022-11-03

On-Brand Devices [Speed-Torque®]

10860003987367Speed-Torque® BNS
10860003987350Speed-Torque® Device Pouch

Trademark Results [Speed-Torque]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SPEED-TORQUE
SPEED-TORQUE
88675261 not registered Live/Pending
Vascugenix, Inc
2019-10-31

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