Quick-Cross Extreme 518-078

GUDID 20813132029474

Quick-Cross Extreme Support Catheter

Philips Image Guided Therapy Corporation

Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use

• Primary Device ID: 20813132029474
• NIH Device Record Key: e6b6fea2-abe3-4d20-8e56-a1bc47dea80c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Quick-Cross Extreme
• Version Model Number: 518-078-B
• Catalog Number: 518-078
• 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: 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: 1-800-633-0960
• Email: SPNC-complaints@philips.com
• Phone: 1-800-633-0960
• Email: SPNC-complaints@philips.com
• Phone: 1-800-633-0960
• Email: SPNC-complaints@philips.com
• Phone: 1-800-633-0960
• Email: SPNC-complaints@philips.com
• Phone: 1-800-633-0960
• Email: SPNC-complaints@philips.com
• Phone: 1-800-633-0960
• Email: SPNC-complaints@philips.com
• Phone: 1-800-633-0960
• Email: SPNC-complaints@philips.com
• Phone: 1-800-633-0960
• Email: SPNC-complaints@philips.com
• Phone: 1-800-633-0960
• Email: SPNC-complaints@philips.com
• Phone: 1-800-633-0960
• Email: SPNC-complaints@philips.com
• Phone: 1-800-633-0960
• Email: SPNC-complaints@philips.com
• Phone: 1-800-633-0960
• Email: SPNC-complaints@philips.com
• Phone: 1-800-633-0960
• Email: SPNC-complaints@philips.com
• Phone: 1-800-633-0960
• Email: SPNC-complaints@philips.com
• Phone: 1-800-633-0960
• Email: SPNC-complaints@philips.com
• Phone: 1-800-633-0960
• Email: SPNC-complaints@philips.com
• Phone: 1-800-633-0960
• Email: SPNC-complaints@philips.com

Device Dimensions

• Lumen/Inner Diameter: 0.035 Inch
• Length: 90 Centimeter
• Lumen/Inner Diameter: 0.035 Inch
• Length: 90 Centimeter
• Lumen/Inner Diameter: 0.035 Inch
• Length: 90 Centimeter
• Lumen/Inner Diameter: 0.035 Inch
• Length: 90 Centimeter
• Lumen/Inner Diameter: 0.035 Inch
• Length: 90 Centimeter
• Lumen/Inner Diameter: 0.035 Inch
• Length: 90 Centimeter
• Lumen/Inner Diameter: 0.035 Inch
• Length: 90 Centimeter
• Lumen/Inner Diameter: 0.035 Inch
• Length: 90 Centimeter
• Lumen/Inner Diameter: 0.035 Inch
• Length: 90 Centimeter
• Lumen/Inner Diameter: 0.035 Inch
• Length: 90 Centimeter
• Lumen/Inner Diameter: 0.035 Inch
• Length: 90 Centimeter
• Lumen/Inner Diameter: 0.035 Inch
• Length: 90 Centimeter
• Lumen/Inner Diameter: 0.035 Inch
• Length: 90 Centimeter
• Lumen/Inner Diameter: 0.035 Inch
• Length: 90 Centimeter
• Lumen/Inner Diameter: 0.035 Inch
• Length: 90 Centimeter
• Lumen/Inner Diameter: 0.035 Inch
• Length: 90 Centimeter
• Lumen/Inner Diameter: 0.035 Inch
• Length: 90 Centimeter

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813132029470 [Primary]
GS1	20813132029474 [Package]; Contains: 00813132029470; Package: Box [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150201

FDA Product Code

• DQY: Catheter, Percutaneous

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-10-12
• Device Publish Date: 2023-10-04

On-Brand Devices [Quick-Cross Extreme]

• 20813132029498: Quick-Cross Extreme Support Catheter
• 20813132029481: Quick-Cross Extreme Support Catheter
• 20813132029474: Quick-Cross Extreme Support Catheter
• 00813132029463: Quick-Cross Extreme Support Catheter
• 20813132029450: Quick-Cross Extreme Support Catheter
• 20813132029443: Quick-Cross Extreme Support Catheter
• 20813132029436: Quick-Cross Extreme Support Catheter
• 20813132029429: Quick-Cross Extreme Support Catheter
• 20813132029412: Quick-Cross Extreme Support Catheter