TightRail Guardian 575-013

GUDID 00813132027445

TightRail Guardian Motorized Dialtor Sheath, 13F

Philips Image Guided Therapy Corporation

Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use

• Primary Device ID: 00813132027445
• NIH Device Record Key: 58a65a7c-d47a-46f9-8144-b54187cf712c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TightRail Guardian
• Version Model Number: 575-013
• Catalog Number: 575-013
• Company DUNS: 118354223
• Company Name: Philips Image Guided Therapy Corporation
• 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: true
• 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: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: complaints@spnc.com

Device Dimensions

• Lumen/Inner Diameter: 0.171 Inch
• Lumen/Inner Diameter: 0.171 Inch
• Lumen/Inner Diameter: 0.171 Inch
• Lumen/Inner Diameter: 0.171 Inch
• Lumen/Inner Diameter: 0.171 Inch
• Lumen/Inner Diameter: 0.171 Inch
• Lumen/Inner Diameter: 0.171 Inch
• Lumen/Inner Diameter: 0.171 Inch
• Lumen/Inner Diameter: 0.171 Inch
• Lumen/Inner Diameter: 0.171 Inch
• Lumen/Inner Diameter: 0.171 Inch
• Lumen/Inner Diameter: 0.171 Inch
• Lumen/Inner Diameter: 0.171 Inch
• Lumen/Inner Diameter: 0.171 Inch
• Lumen/Inner Diameter: 0.171 Inch
• Lumen/Inner Diameter: 0.171 Inch
• Lumen/Inner Diameter: 0.171 Inch
• Lumen/Inner Diameter: 0.171 Inch
• Lumen/Inner Diameter: 0.171 Inch
• Lumen/Inner Diameter: 0.171 Inch
• Lumen/Inner Diameter: 0.171 Inch
• Lumen/Inner Diameter: 0.171 Inch
• Lumen/Inner Diameter: 0.171 Inch
• Lumen/Inner Diameter: 0.171 Inch
• Lumen/Inner Diameter: 0.171 Inch
• Lumen/Inner Diameter: 0.171 Inch
• Lumen/Inner Diameter: 0.171 Inch
• Lumen/Inner Diameter: 0.171 Inch
• Lumen/Inner Diameter: 0.171 Inch
• Lumen/Inner Diameter: 0.171 Inch
• Lumen/Inner Diameter: 0.171 Inch
• Lumen/Inner Diameter: 0.171 Inch
• Lumen/Inner Diameter: 0.171 Inch
• Lumen/Inner Diameter: 0.171 Inch
• Lumen/Inner Diameter: 0.171 Inch
• Lumen/Inner Diameter: 0.171 Inch

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813132027445 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K223472

FDA Product Code

• DRE: Dilator, Vessel, For Percutaneous Catheterization

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-08-02
• Device Publish Date: 2023-01-10

On-Brand Devices [TightRail Guardian ]

• 00813132027445: TightRail Guardian Motorized Dialtor Sheath, 13F
• 00813132027438: TightRail Guardian Motorized Dialtor Sheath, 11F
• 00813132027421: TightRail Guardian Motorized Dialtor Sheath, 9F