Quiktork Guidewire Torque Device TOR-100-10

GUDID 10841268108353

Quiktork Guidewire Torque Device

GALT MEDICAL CORP.

Peripheral vascular guidewire, manual
Primary Device ID10841268108353
NIH Device Record Key499bd192-27a9-402f-aed7-c3d0d6eabd12
Commercial Distribution StatusIn Commercial Distribution
Brand NameQuiktork Guidewire Torque Device
Version Model NumberTOR-100-10
Catalog NumberTOR-100-10
Company DUNS943156836
Company NameGALT MEDICAL CORP.
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 Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-639-2800
Emailcustomerservice@galtneedletech.com
Phone800-639-2800
Emailcustomerservice@galtneedletech.com
Phone800-639-2800
Emailcustomerservice@galtneedletech.com
Phone800-639-2800
Emailcustomerservice@galtneedletech.com
Phone800-639-2800
Emailcustomerservice@galtneedletech.com
Phone800-639-2800
Emailcustomerservice@galtneedletech.com
Phone800-639-2800
Emailcustomerservice@galtneedletech.com
Phone800-639-2800
Emailcustomerservice@galtneedletech.com
Phone800-639-2800
Emailcustomerservice@galtneedletech.com
Phone800-639-2800
Emailcustomerservice@galtneedletech.com

Device Dimensions

Guidewire Diameter0.01 Inch
Guidewire Diameter0.01 Inch
Guidewire Diameter0.01 Inch
Guidewire Diameter0.01 Inch
Guidewire Diameter0.01 Inch
Guidewire Diameter0.01 Inch
Guidewire Diameter0.01 Inch
Guidewire Diameter0.01 Inch
Guidewire Diameter0.01 Inch

Device Identifiers

Device Issuing AgencyDevice ID
GS100841268108356 [Primary]
GS110841268108353 [Package]
Contains: 00841268108356
Package: Shelf [10 Units]
In Commercial Distribution
GS120841268108350 [Package]
Package: Shipper [40 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DQXWire, Guide, Catheter

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[10841268108353]

Ethylene Oxide


[10841268108353]

Ethylene Oxide


[10841268108353]

Ethylene Oxide


[10841268108353]

Ethylene Oxide


[10841268108353]

Ethylene Oxide


[10841268108353]

Ethylene Oxide


[10841268108353]

Ethylene Oxide


[10841268108353]

Ethylene Oxide


[10841268108353]

Ethylene Oxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-03-05
Device Publish Date2026-02-25

On-Brand Devices [Quiktork Guidewire Torque Device]

10841268108360Quiktork Guidewire Torque Device
10841268108353Quiktork Guidewire Torque Device

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