Synchro SELECT SSFT215PRE

GUDID 07613327508598

SOFT PRE-SHAPED Guidewire with Hydrophilic Coating

Stryker Corporation

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: 07613327508598
• NIH Device Record Key: 66e89338-45c4-475f-ba3b-0c4661322702
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Synchro SELECT
• Version Model Number: SSFT215PRE
• Catalog Number: SSFT215PRE
• Company DUNS: 042405446
• Company Name: Stryker 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: 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

Device Dimensions

• Length: 215 Centimeter
• Outer Diameter: 0.014 Inch
• Length: 215 Centimeter
• Outer Diameter: 0.014 Inch
• Length: 215 Centimeter
• Outer Diameter: 0.014 Inch
• Length: 215 Centimeter
• Outer Diameter: 0.014 Inch
• Length: 215 Centimeter
• Outer Diameter: 0.014 Inch
• Length: 215 Centimeter
• Outer Diameter: 0.014 Inch
• Length: 215 Centimeter
• Outer Diameter: 0.014 Inch
• Length: 215 Centimeter
• Outer Diameter: 0.014 Inch
• Length: 215 Centimeter
• Outer Diameter: 0.014 Inch
• Length: 215 Centimeter
• Outer Diameter: 0.014 Inch
• Length: 215 Centimeter
• Outer Diameter: 0.014 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.

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327508598 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202522

FDA Product Code

• DQX: Wire, guide, catheter

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: 2020-10-28
• Device Publish Date: 2020-10-20

On-Brand Devices [Synchro SELECT]

• 07613327508642: SUPPORT PRE-SHAPED Guidewire with Hydrophilic Coating
• 07613327508635: SUPPORT PRE-SHAPED Guidewire with Hydrophilic Coating
• 07613327508628: SUPPORT STRAIGHT Guidewire with Hydrophilic Coating
• 07613327508611: SUPPORT STRAIGHT Guidewire with Hydrophilic Coating
• 07613327508604: SOFT PRE-SHAPED Guidewire with Hydrophilic Coating
• 07613327508598: SOFT PRE-SHAPED Guidewire with Hydrophilic Coating
• 07613327508581: SOFT STRAIGHT Guidewire with Hydrophilic Coating
• 07613327508574: SOFT STRAIGHT Guidewire with Hydrophilic Coating
• 07613327508529: STANDARD PRE-SHAPED Guidewire with Hydrophilic Coating
• 07613327508512: STANDARD PRE-SHAPED Guidewire with Hydrophilic Coating
• 07613327508505: STANDARD STRAIGHT Guidewire with Hydrophilic Coating
• 07613327508499: STANDARD STRAIGHT Guidewire with Hydrophilic Coating