PowerWire Pro Radiofrequency Guidewire Kit

GUDID 07540299000419

PowerWire Pro RF Guidewire; RFP-100A Connector Cable

Baylis Medical Technologies Inc

Endoscopic electrosurgical electrode, monopolar, single-use

• Primary Device ID: 07540299000419
• NIH Device Record Key: c57e721c-c258-439f-bc3e-81831dc7c3c4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PowerWire Pro Radiofrequency Guidewire Kit
• Version Model Number: PSK35-250-12-6S
• Company DUNS: 240389677
• Company Name: Baylis Medical Technologies Inc
• 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: 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: 905-948-5800
• Email: info@baylismedtech.com
• Phone: 905-948-5800
• Email: info@baylismedtech.com
• Phone: 905-948-5800
• Email: info@baylismedtech.com
• Phone: 905-948-5800
• Email: info@baylismedtech.com
• Phone: 905-948-5800
• Email: info@baylismedtech.com
• Phone: 905-948-5800
• Email: info@baylismedtech.com
• Phone: 905-948-5800
• Email: info@baylismedtech.com
• Phone: 905-948-5800
• Email: info@baylismedtech.com
• Phone: 905-948-5800
• Email: info@baylismedtech.com
• Phone: 905-948-5800
• Email: info@baylismedtech.com
• Phone: 905-948-5800
• Email: info@baylismedtech.com
• Phone: 905-948-5800
• Email: info@baylismedtech.com
• Phone: 905-948-5800
• Email: info@baylismedtech.com
• Phone: 905-948-5800
• Email: info@baylismedtech.com
• Phone: 905-948-5800
• Email: info@baylismedtech.com
• Phone: 905-948-5800
• Email: info@baylismedtech.com
• Phone: 905-948-5800
• Email: info@baylismedtech.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	07540299000419 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232562

FDA Product Code

• PDU: Catheter For Crossing Total Occlusions

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: 2024-03-26
• Device Publish Date: 2024-03-18

On-Brand Devices [PowerWire Pro Radiofrequency Guidewire Kit]

• 07540299000419: PowerWire Pro RF Guidewire; RFP-100A Connector Cable
• 07540299000402: PowerWire Pro RF Guidewire; RFP-100A Connector Cable
• 07540299000396: PowerWire Pro RF Guidewire; RFP-100A Connector Cable
• 07540299000389: PowerWire Pro RF Guidewire; RFP-100A Connector Cable
• 07540299000372: PowerWire Pro RF Guidewire; RFP-100A Connector Cable