taperflo™ W50ST0407CRS

GUDID 05037881009889

taperflo Gelatin Sealed ePTFE Vascular Prosthesis Stepped Taper with Wrap and Central Support

VASCUTEK LTD

Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft

• Primary Device ID: 05037881009889
• NIH Device Record Key: d65362ef-aacb-4b80-a293-55e1d4113283
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: taperflo™
• Version Model Number: W50ST0407CRS
• Catalog Number: W50ST0407CRS
• Company DUNS: 229053087
• Company Name: VASCUTEK LTD
• 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: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)888-3786
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)888-3786
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)888-3786
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)888-3786
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)888-3786
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)888-3786
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)888-3786
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)888-3786
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)888-3786
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)888-3786
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)888-3786
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)888-3786
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)888-3786
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)888-3786
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)888-3786
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)888-3786
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)888-3786
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)888-3786
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)888-3786
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)888-3786
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)888-3786
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)888-3786
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)888-3786
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)888-3786
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)888-3786
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)888-3786
• Email: tmccustomer.admin@terumomedical.com

Device Dimensions

• Length: 50 Centimeter
• Length: 50 Centimeter
• Length: 50 Centimeter
• Length: 50 Centimeter
• Device Size Text, specify: 0
• Length: 50 Centimeter
• Device Size Text, specify: 0
• Length: 50 Centimeter
• Device Size Text, specify: 0
• Length: 50 Centimeter
• Device Size Text, specify: 0
• Length: 50 Centimeter
• Device Size Text, specify: 0
• Length: 50 Centimeter
• Device Size Text, specify: 0
• Length: 50 Centimeter
• Device Size Text, specify: 0
• Length: 50 Centimeter
• Device Size Text, specify: 0
• Length: 50 Centimeter
• Device Size Text, specify: 0
• Length: 50 Centimeter
• Device Size Text, specify: 0
• Length: 50 Centimeter
• Device Size Text, specify: 0
• Length: 50 Centimeter
• Device Size Text, specify: 0
• Length: 50 Centimeter
• Device Size Text, specify: 0
• Length: 50 Centimeter
• Device Size Text, specify: 0
• Length: 50 Centimeter
• Device Size Text, specify: 0
• Length: 50 Centimeter
• Device Size Text, specify: 0
• Length: 50 Centimeter
• Device Size Text, specify: 0
• Length: 50 Centimeter
• Device Size Text, specify: 0
• Length: 50 Centimeter
• Device Size Text, specify: 0
• Length: 50 Centimeter
• Device Size Text, specify: 0
• Length: 50 Centimeter
• Device Size Text, specify: 0
• Length: 50 Centimeter
• Device Size Text, specify: 0
• Length: 50 Centimeter
• Device Size Text, specify: 0
• Length: 50 Centimeter
• Device Size Text, specify: 0
• Length: 50 Centimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry area at room temperature. Do not expose ePTFE products to temperature greater than 500°F (260 °C).
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry area at room temperature. Do not expose ePTFE products to temperature greater than 500°F (260 °C).
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry area at room temperature. Do not expose ePTFE products to temperature greater than 500°F (260 °C).
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry area at room temperature. Do not expose ePTFE products to temperature greater than 500°F (260 °C).
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry area at room temperature. Do not expose ePTFE products to temperature greater than 500°F (260 °C).
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry area at room temperature. Do not expose ePTFE products to temperature greater than 500°F (260 °C).
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry area at room temperature. Do not expose ePTFE products to temperature greater than 500°F (260 °C).
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry area at room temperature. Do not expose ePTFE products to temperature greater than 500°F (260 °C).
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry area at room temperature. Do not expose ePTFE products to temperature greater than 500°F (260 °C).
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry area at room temperature. Do not expose ePTFE products to temperature greater than 500°F (260 °C).
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry area at room temperature. Do not expose ePTFE products to temperature greater than 500°F (260 °C).
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry area at room temperature. Do not expose ePTFE products to temperature greater than 500°F (260 °C).
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry area at room temperature. Do not expose ePTFE products to temperature greater than 500°F (260 °C).
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry area at room temperature. Do not expose ePTFE products to temperature greater than 500°F (260 °C).
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry area at room temperature. Do not expose ePTFE products to temperature greater than 500°F (260 °C).
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry area at room temperature. Do not expose ePTFE products to temperature greater than 500°F (260 °C).
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry area at room temperature. Do not expose ePTFE products to temperature greater than 500°F (260 °C).
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry area at room temperature. Do not expose ePTFE products to temperature greater than 500°F (260 °C).
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry area at room temperature. Do not expose ePTFE products to temperature greater than 500°F (260 °C).
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry area at room temperature. Do not expose ePTFE products to temperature greater than 500°F (260 °C).
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry area at room temperature. Do not expose ePTFE products to temperature greater than 500°F (260 °C).
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry area at room temperature. Do not expose ePTFE products to temperature greater than 500°F (260 °C).
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry area at room temperature. Do not expose ePTFE products to temperature greater than 500°F (260 °C).
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry area at room temperature. Do not expose ePTFE products to temperature greater than 500°F (260 °C).
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry area at room temperature. Do not expose ePTFE products to temperature greater than 500°F (260 °C).
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry area at room temperature. Do not expose ePTFE products to temperature greater than 500°F (260 °C).
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry area at room temperature. Do not expose ePTFE products to temperature greater than 500°F (260 °C).

Device Identifiers

Device Issuing Agency	Device ID
GS1	05037881009889 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092863

FDA Product Code

• DSY: PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-03-24
• Device Publish Date: 2015-09-23

On-Brand Devices [taperflo™]

• 05037881009889: taperflo Gelatin Sealed ePTFE Vascular Prosthesis Stepped Taper with Wrap and Central Support
• 05037881009872: taperflo Gelatin Sealed ePTFE Vascular Prosthesis Stepped Taper with Wrap and Central Support
• 05037881009865: taperflo Gelatin Sealed ePTFE Vascular Prosthesis Stepped Taper with Wrap and Central Support
• 05037881009858: taperflo Gelatin Sealed ePTFE Vascular Prosthesis Stepped Taper with Wrap and Central Support
• 05037881009841: taperflo Gelatin Sealed ePTFE Vascular Prosthesis Stepped Taper with Wrap
• 05037881009834: taperflo Gelatin Sealed ePTFE Vascular Prosthesis Stepped Taper with Wrap
• 05037881009827: taperflo Gelatin Sealed ePTFE Vascular Prosthesis Stepped Taper with Wrap
• 05037881009810: taperflo Gelatin Sealed ePTFE Vascular Prosthesis Stepped Taper with Wrap
• 05037881009803: taperflo Gelatin Sealed ePTFE Vascular Prosthesis Stepped Taper with Wrap
• 05037881009797: taperflo Gelatin Sealed ePTFE Vascular Prosthesis Stepped Taper with Wrap
• 05037881009780: taperflo Gelatin Sealed ePTFE Vascular Prosthesis Stepped Taper with Wrap
• 05037881009773: taperflo Gelatin Sealed ePTFE Vascular Prosthesis Stepped Taper with Wrap
• 05037881009766: taperflo Gelatin Sealed ePTFE Vascular Prosthesis Stepped Taper with Wrap
• 05037881009759: taperflo Gelatin Sealed ePTFE Vascular Prosthesis Stepped Taper with Wrap
• 05037881009742: taperflo Gelatin Sealed ePTFE Vascular Prosthesis Stepped Taper with Wrap
• 05037881009735: taperflo Gelatin Sealed ePTFE Vascular Prosthesis Stepped Taper with Wrap
• 05037881009728: taperflo Gelatin Sealed ePTFE Vascular Prosthesis Stepped Taper with Wrap
• 05037881009711: taperflo Gelatin Sealed ePTFE Vascular Prosthesis Stepped Taper with Wrap
• 05037881009704: taperflo Gelatin Sealed ePTFE Vascular Prosthesis Stepped Taper with Wrap
• 05037881009698: taperflo Gelatin Sealed ePTFE Vascular Prosthesis Stepped Taper with Wrap
• 05037881009681: taperflo Gelatin Sealed ePTFE Vascular Prosthesis Stepped Taper with Wrap
• 05037881009674: taperflo Gelatin Sealed ePTFE Vascular Prosthesis Stepped Taper with Wrap
• 05037881009667: taperflo Gelatin Sealed ePTFE Vascular Prosthesis Stepped Taper with Wrap and Central Support
• 05037881009650: taperflo Gelatin Sealed ePTFE Vascular Prosthesis Stepped Taper with Wrap and Central Support
• 05037881009643: taperflo Gelatin Sealed ePTFE Vascular Prosthesis Stepped Taper with Wrap and Central Support
• 05037881009636: taperflo Gelatin Sealed ePTFE Vascular Prosthesis Short Taper with Wrap
• 05037881009629: taperflo Gelatin Sealed ePTFE Vascular Prosthesis Short Taper with Wrap
• 05037881009612: taperflo Gelatin Sealed ePTFE Vascular Prosthesis Short Taper with Wrap
• 05037881009605: taperflo Gelatin Sealed ePTFE Vascular Prosthesis Short Taper with Wrap
• 05037881009599: taperflo Gelatin Sealed ePTFE Vascular Prosthesis Short Taper with Wrap
• 05037881009582: taperflo Gelatin Sealed ePTFE Vascular Prosthesis Stepped Taper with Wrap