PowerWire Radiofrequency GuideWire Kit

GUDID 07540299000228

PowerWire RF GuideWire; RFP-100A Connector Cable

Baylis Medical Technologies Inc

Endoscopic electrosurgical electrode, monopolar, single-use

• Primary Device ID: 07540299000228
• NIH Device Record Key: 453685fd-ab99-43e6-88a5-d94ad8397850
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PowerWire Radiofrequency GuideWire Kit
• Version Model Number: EWK35-250-12-6A-20-05
• 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
• 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

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00685447001089 [Previous]
GS1	07540299000228 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101615

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: 2023-07-04
• Device Publish Date: 2023-06-26

On-Brand Devices [PowerWire Radiofrequency GuideWire Kit]

• 07540299000273: PowerWire RF GuideWire; RFP-100A Connector Cable
• 07540299000266: PowerWire RF GuideWire; RFP-100A Connector Cable
• 07540299000259: PowerWire RF GuideWire; RFP-100A Connector Cable
• 07540299000242: PowerWire RF GuideWire; RFP-100A Connector Cable
• 07540299000235: PowerWire RF GuideWire; RFP-100A Connector Cable
• 07540299000228: PowerWire RF GuideWire; RFP-100A Connector Cable