Synchro2 S2SPP14300

GUDID 07613327459661

SUPPORT PRE-SHAPED Guidewire with Hydrophilic Coating

Stryker Corporation

Cardiac/peripheral vascular guidewire, single-use

• Primary Device ID: 07613327459661
• NIH Device Record Key: 3ef1f151-fedf-4952-93a8-076f3bc23381
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Synchro2
• Version Model Number: S2SPP14300
• Catalog Number: S2SPP14300
• 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

Device Dimensions

• Outer Diameter: 0.014 Inch

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327459661 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190843

FDA Product Code

• MOF: GUIDE, WIRE, CATHETER, NEUROVASCULATURE

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: 2019-06-28
• Device Publish Date: 2019-06-20

On-Brand Devices [Synchro2]

• 07613327459661: SUPPORT PRE-SHAPED Guidewire with Hydrophilic Coating
• 07613327459654: SUPPORT PRE-SHAPED Guidewire with Hydrophilic Coating
• 07613327459647: SUPPORT Guidewire with Hydrophilic Coating
• 07613327459630: SUPPORT Guidewire with Hydrophilic Coating