HydroSteer™ 405075

GUDID 15414734055137

ST. JUDE MEDICAL CARDIOVASCULAR DIVISION

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: 15414734055137
• NIH Device Record Key: 62f63a07-f149-40e2-b7d0-63c4d856133b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HydroSteer™
• Version Model Number: 405075
• Catalog Number: 405075
• Company DUNS: 040960379
• Company Name: ST. JUDE MEDICAL CARDIOVASCULAR DIVISION
• 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: 0.038 Inch
• Length: 180 Centimeter
• Outer Diameter: 0.038 Inch
• Length: 180 Centimeter
• Outer Diameter: 0.038 Inch
• Length: 180 Centimeter
• Outer Diameter: 0.038 Inch
• Length: 180 Centimeter
• Outer Diameter: 0.038 Inch
• Length: 180 Centimeter
• Outer Diameter: 0.038 Inch
• Length: 180 Centimeter
• Outer Diameter: 0.038 Inch
• Length: 180 Centimeter
• Outer Diameter: 0.038 Inch
• Length: 180 Centimeter
• Outer Diameter: 0.038 Inch
• Length: 180 Centimeter
• Outer Diameter: 0.038 Inch
• Length: 180 Centimeter
• Outer Diameter: 0.038 Inch
• Length: 180 Centimeter
• Outer Diameter: 0.038 Inch
• Length: 180 Centimeter
• Outer Diameter: 0.038 Inch
• Length: 180 Centimeter
• Outer Diameter: 0.038 Inch
• Length: 180 Centimeter
• Outer Diameter: 0.038 Inch
• Length: 180 Centimeter

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	05414734055130 [Primary]
GS1	15414734055137 [Package]; Contains: 05414734055130; 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™]

• 15414734055199: Guidewires
• 15414734055182: Guidewires
• 15414734055175: Guidewires
• 15414734055168: Guidewires
• 15414734055151: Guidewires
• 15414734055144: Guidewires
• 15414734055137: 405075
• 15414734055120: Guidewires
• 15414734055113: Guidewires
• 15414734055106: Guidewires
• 15414734055090: Guidewires
• 15414734055083: Guidewires
• 15414734055076: 405069
• 15414734055069: 405068
• 15414734055052: 405067
• 15414734055045: Guidewires
• 15414734055038: 405065
• 15414734055021: 405064
• 15414734055007: 405062
• 15414734054987: 405060
• 15414734054970: Guidewires
• 15414734054963: Guidewires
• 15414734054949: 405056
• 15414734054932: Guidewires
• 15414734054925: Guidewires
• 15414734054918: Guidewires
• 15414734028506: 405083
• 15414734028490: 405082