SPIROFLEX 106553

GUDID 00616258003887

SPIROFLEX CUS CATH, FG PKG

Bayer Healthcare LLC

Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter

• Primary Device ID: 00616258003887
• NIH Device Record Key: bd30fdf3-3e8a-4482-9c72-7dbde2ce10ae
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SPIROFLEX
• Version Model Number: 106553-001
• Catalog Number: 106553
• Company DUNS: 079415074
• Company Name: Bayer Healthcare LLC
• 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: 763-780-4555
• Email: michael.burnside@bayer.com
• Phone: 763-780-4555
• Email: michael.burnside@bayer.com
• Phone: 763-780-4555
• Email: michael.burnside@bayer.com
• Phone: 763-780-4555
• Email: michael.burnside@bayer.com
• Phone: 763-780-4555
• Email: michael.burnside@bayer.com
• Phone: 763-780-4555
• Email: michael.burnside@bayer.com
• Phone: 763-780-4555
• Email: michael.burnside@bayer.com
• Phone: 763-780-4555
• Email: michael.burnside@bayer.com
• Phone: 763-780-4555
• Email: michael.burnside@bayer.com
• Phone: 763-780-4555
• Email: michael.burnside@bayer.com
• Phone: 763-780-4555
• Email: michael.burnside@bayer.com
• Phone: 763-780-4555
• Email: michael.burnside@bayer.com
• Phone: 763-780-4555
• Email: michael.burnside@bayer.com

Device Dimensions

• Catheter Gauge: 4 French
• Catheter Gauge: 4 French
• Catheter Gauge: 4 French
• Catheter Gauge: 4 French
• Catheter Gauge: 4 French
• Catheter Gauge: 4 French
• Catheter Gauge: 4 French
• Catheter Gauge: 4 French
• Catheter Gauge: 4 French
• Catheter Gauge: 4 French
• Catheter Gauge: 4 French
• Catheter Gauge: 4 French
• Catheter Gauge: 4 French

Device Identifiers

Device Issuing Agency	Device ID
GS1	00616258003887 [Primary]

FDA Product Code

• DXE: Catheter, Embolectomy

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2014-10-09

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