NorthStar Coronary Sinus Guidewire

GUDID 00685447005575

Baylis Médicale Cie Inc

Cardiac/peripheral vascular guidewire, single-use

• Primary Device ID: 00685447005575
• NIH Device Record Key: a56f1d7b-649e-44c5-999a-c7e65bd7bc3d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NorthStar Coronary Sinus Guidewire
• Version Model Number: NGW-14-190-D-J
• Company DUNS: 249225954
• Company Name: Baylis Médicale Cie 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: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
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• Email: info@baylismedical.com
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• Email: info@baylismedical.com
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• Email: info@baylismedical.com
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• Email: info@baylismedical.com
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• Email: info@baylismedical.com
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• Email: info@baylismedical.com
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• Email: info@baylismedical.com
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• Email: info@baylismedical.com
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• Email: info@baylismedical.com
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• Email: info@baylismedical.com
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• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
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• Email: info@baylismedical.com
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• Email: info@baylismedical.com
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• Email: info@baylismedical.com
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• Email: info@baylismedical.com
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• Email: info@baylismedical.com
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• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
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• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com

Device Dimensions

• Device Size Text, specify: 0
• Outer Diameter: 0.014 Inch
• Length: 190 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 0.014 Inch
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• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• Length: 190 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 0.014 Inch
• Length: 190 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00685447005575 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141831

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: 2020-08-25
• Device Publish Date: 2020-08-17

On-Brand Devices [NorthStar Coronary Sinus Guidewire]

• 00685447005599: NGW-14-190-XD-J
• 00685447005582: NGW-14-190-X-J
• 00685447005575: NGW-14-190-D-J
• 00685447005568: NGW-14-190-XD
• 00685447005551: NGW-14-190-X
• 00685447005544: NGW-14-190-D