HydroSteer™ 405061

GUDID 15414734054994

Guidewires

ST. JUDE MEDICAL, INC.

Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use

• Primary Device ID: 15414734054994
• NIH Device Record Key: 06474516-6bb9-4e35-88f0-af944dc7d494
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HydroSteer™
• Version Model Number: 405061
• Catalog Number: 405061
• Company DUNS: 149818952
• Company Name: ST. JUDE MEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com

Device Dimensions

• Outer Diameter: 0.035 Inch
• Length: 180 Centimeter
• Outer Diameter: 0.89 Millimeter
• Outer Diameter: 0.035 Inch
• Length: 180 Centimeter
• Outer Diameter: 0.89 Millimeter
• Outer Diameter: 0.035 Inch
• Length: 180 Centimeter
• Outer Diameter: 0.89 Millimeter
• Outer Diameter: 0.035 Inch
• Length: 180 Centimeter
• Outer Diameter: 0.89 Millimeter
• Outer Diameter: 0.035 Inch
• Length: 180 Centimeter
• Outer Diameter: 0.89 Millimeter
• Outer Diameter: 0.035 Inch
• Length: 180 Centimeter
• Outer Diameter: 0.89 Millimeter
• Outer Diameter: 0.035 Inch
• Length: 180 Centimeter
• Outer Diameter: 0.89 Millimeter
• Outer Diameter: 0.035 Inch
• Length: 180 Centimeter
• Outer Diameter: 0.89 Millimeter
• Outer Diameter: 0.035 Inch
• Length: 180 Centimeter
• Outer Diameter: 0.89 Millimeter
• Outer Diameter: 0.035 Inch
• Length: 180 Centimeter
• Outer Diameter: 0.89 Millimeter
• Outer Diameter: 0.035 Inch
• Length: 180 Centimeter
• Outer Diameter: 0.89 Millimeter
• Outer Diameter: 0.035 Inch
• Length: 180 Centimeter
• Outer Diameter: 0.89 Millimeter
• Outer Diameter: 0.035 Inch
• Length: 180 Centimeter
• Outer Diameter: 0.89 Millimeter
• Outer Diameter: 0.035 Inch
• Length: 180 Centimeter
• Outer Diameter: 0.89 Millimeter
• Outer Diameter: 0.035 Inch
• Length: 180 Centimeter
• Outer Diameter: 0.89 Millimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE.
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE.
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE.
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE.
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE.
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE.
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE.
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE.
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE.
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE.
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE.
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE.
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE.
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE.
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE.

Device Identifiers

Device Issuing Agency	Device ID
GS1	05414734054997 [Primary]
GS1	15414734054994 [Package]; Contains: 05414734054997; Package: [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K000011

FDA Product Code

• DQX: WIRE, GUIDE, CATHETER

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-09-14

On-Brand Devices [HydroSteer™]

• 15414734055205: Torque Device
• 15414734055014: Guidewires
• 15414734054994: Guidewires
• 15414734054956: Guidewires
• 15414734028322: Guidewires