AXS Catalyst 5 IC058115

GUDID 07613327012019

Distal Access Catheter

Stryker 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 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 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: 07613327012019
• NIH Device Record Key: 23d9a694-7a99-4245-ba06-51396f7307a4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AXS Catalyst 5
• Version Model Number: M003IC0581150
• Catalog Number: IC058115
• Company DUNS: 042405446
• Company Name: Stryker Corporation
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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)916-3876
• Email: NVCustomerService@stryker.com
• Phone: +1(855)916-3876
• Email: NVCustomerService@stryker.com
• Phone: +1(855)916-3876
• Email: NVCustomerService@stryker.com
• Phone: +1(855)916-3876
• Email: NVCustomerService@stryker.com
• Phone: +1(855)916-3876
• Email: NVCustomerService@stryker.com
• Phone: +1(855)916-3876
• Email: NVCustomerService@stryker.com
• Phone: +1(855)916-3876
• Email: NVCustomerService@stryker.com
• Phone: +1(855)916-3876
• Email: NVCustomerService@stryker.com
• Phone: +1(855)916-3876
• Email: NVCustomerService@stryker.com
• Phone: +1(855)916-3876
• Email: NVCustomerService@stryker.com
• Phone: +1(855)916-3876
• Email: NVCustomerService@stryker.com
• Phone: +1(855)916-3876
• Email: NVCustomerService@stryker.com
• Phone: +1(855)916-3876
• Email: NVCustomerService@stryker.com
• Phone: +1(855)916-3876
• Email: NVCustomerService@stryker.com
• Phone: +1(855)916-3876
• Email: NVCustomerService@stryker.com
• Phone: +1(855)916-3876
• Email: NVCustomerService@stryker.com
• Phone: +1(855)916-3876
• Email: NVCustomerService@stryker.com
• Phone: +1(855)916-3876
• Email: NVCustomerService@stryker.com
• Phone: +1(855)916-3876
• Email: NVCustomerService@stryker.com
• Phone: +1(855)916-3876
• Email: NVCustomerService@stryker.com
• Phone: +1(855)916-3876
• Email: NVCustomerService@stryker.com
• Phone: +1(855)916-3876
• Email: NVCustomerService@stryker.com
• Phone: +1(855)916-3876
• Email: NVCustomerService@stryker.com
• Phone: +1(855)916-3876
• Email: NVCustomerService@stryker.com
• Phone: +1(855)916-3876
• Email: NVCustomerService@stryker.com
• Phone: +1(855)916-3876
• Email: NVCustomerService@stryker.com
• Phone: +1(855)916-3876
• Email: NVCustomerService@stryker.com
• Phone: +1(855)916-3876
• Email: NVCustomerService@stryker.com
• Phone: +1(855)916-3876
• Email: NVCustomerService@stryker.com
• Phone: +1(855)916-3876
• Email: NVCustomerService@stryker.com
• Phone: +1(855)916-3876
• Email: NVCustomerService@stryker.com
• Phone: +1(855)916-3876
• Email: NVCustomerService@stryker.com
• Phone: +1(855)916-3876
• Email: NVCustomerService@stryker.com
• Phone: +1(855)916-3876
• Email: NVCustomerService@stryker.com
• Phone: +1(855)916-3876
• Email: NVCustomerService@stryker.com
• Phone: +1(855)916-3876
• Email: NVCustomerService@stryker.com
• Phone: +1(855)916-3876
• Email: NVCustomerService@stryker.com
• Phone: +1(855)916-3876
• Email: NVCustomerService@stryker.com
• Phone: +1(855)916-3876
• Email: NVCustomerService@stryker.com
• Phone: +1(855)916-3876
• Email: NVCustomerService@stryker.com

Device Dimensions

• Length: 115 Centimeter
• Lumen/Inner Diameter: 0.058 Inch
• Length: 115 Centimeter
• Lumen/Inner Diameter: 0.058 Inch
• Length: 115 Centimeter
• Lumen/Inner Diameter: 0.058 Inch
• Length: 115 Centimeter
• Lumen/Inner Diameter: 0.058 Inch
• Length: 115 Centimeter
• Lumen/Inner Diameter: 0.058 Inch
• Length: 115 Centimeter
• Lumen/Inner Diameter: 0.058 Inch
• Length: 115 Centimeter
• Lumen/Inner Diameter: 0.058 Inch
• Length: 115 Centimeter
• Lumen/Inner Diameter: 0.058 Inch
• Length: 115 Centimeter
• Lumen/Inner Diameter: 0.058 Inch
• Length: 115 Centimeter
• Lumen/Inner Diameter: 0.058 Inch
• Length: 115 Centimeter
• Lumen/Inner Diameter: 0.058 Inch
• Length: 115 Centimeter
• Lumen/Inner Diameter: 0.058 Inch
• Length: 115 Centimeter
• Lumen/Inner Diameter: 0.058 Inch
• Length: 115 Centimeter
• Lumen/Inner Diameter: 0.058 Inch
• Length: 115 Centimeter
• Lumen/Inner Diameter: 0.058 Inch
• Length: 115 Centimeter
• Lumen/Inner Diameter: 0.058 Inch
• Length: 115 Centimeter
• Lumen/Inner Diameter: 0.058 Inch
• Length: 115 Centimeter
• Lumen/Inner Diameter: 0.058 Inch
• Length: 115 Centimeter
• Lumen/Inner Diameter: 0.058 Inch
• Length: 115 Centimeter
• Lumen/Inner Diameter: 0.058 Inch
• Length: 115 Centimeter
• Lumen/Inner Diameter: 0.058 Inch
• Length: 115 Centimeter
• Lumen/Inner Diameter: 0.058 Inch
• Length: 115 Centimeter
• Lumen/Inner Diameter: 0.058 Inch
• Length: 115 Centimeter
• Lumen/Inner Diameter: 0.058 Inch
• Length: 115 Centimeter
• Lumen/Inner Diameter: 0.058 Inch
• Length: 115 Centimeter
• Lumen/Inner Diameter: 0.058 Inch
• Length: 115 Centimeter
• Lumen/Inner Diameter: 0.058 Inch
• Length: 115 Centimeter
• Lumen/Inner Diameter: 0.058 Inch
• Length: 115 Centimeter
• Lumen/Inner Diameter: 0.058 Inch
• Length: 115 Centimeter
• Lumen/Inner Diameter: 0.058 Inch
• Length: 115 Centimeter
• Lumen/Inner Diameter: 0.058 Inch
• Length: 115 Centimeter
• Lumen/Inner Diameter: 0.058 Inch
• Length: 115 Centimeter
• Lumen/Inner Diameter: 0.058 Inch
• Length: 115 Centimeter
• Lumen/Inner Diameter: 0.058 Inch
• Length: 115 Centimeter
• Lumen/Inner Diameter: 0.058 Inch
• Length: 115 Centimeter
• Lumen/Inner Diameter: 0.058 Inch
• Length: 115 Centimeter
• Lumen/Inner Diameter: 0.058 Inch
• Length: 115 Centimeter
• Lumen/Inner Diameter: 0.058 Inch
• Length: 115 Centimeter
• Lumen/Inner Diameter: 0.058 Inch
• Length: 115 Centimeter
• Lumen/Inner Diameter: 0.058 Inch

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, dark place.

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327012019 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151667

FDA Product Code

• DQY: CATHETER, PERCUTANEOUS

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2019-01-23
• Device Publish Date: 2016-09-21

On-Brand Devices [AXS Catalyst 5]

• 07613327012019: Distal Access Catheter
• 07613327011999: Distal Access Catheter