taperflo™ W35ST0407S

GUDID 05037881009742

taperflo Gelatin Sealed ePTFE Vascular Prosthesis Stepped Taper with Wrap

VASCUTEK LTD

Synthetic vascular graft

• Primary Device ID: 05037881009742
• NIH Device Record Key: b2f1bef8-bbeb-4f44-9c90-c94b5c8b2686
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: taperflo™
• Version Model Number: W35ST0407S
• Catalog Number: W35ST0407S
• 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: 35 Centimeter
• Length: 35 Centimeter
• Length: 35 Centimeter
• Length: 35 Centimeter
• Device Size Text, specify: 0
• Length: 35 Centimeter
• Device Size Text, specify: 0
• Length: 35 Centimeter
• Device Size Text, specify: 0
• Length: 35 Centimeter
• Device Size Text, specify: 0
• Length: 35 Centimeter
• Device Size Text, specify: 0
• Length: 35 Centimeter
• Device Size Text, specify: 0
• Length: 35 Centimeter
• Device Size Text, specify: 0
• Length: 35 Centimeter
• Device Size Text, specify: 0
• Length: 35 Centimeter
• Device Size Text, specify: 0
• Length: 35 Centimeter
• Device Size Text, specify: 0
• Length: 35 Centimeter
• Device Size Text, specify: 0
• Length: 35 Centimeter
• Device Size Text, specify: 0
• Length: 35 Centimeter
• Device Size Text, specify: 0
• Length: 35 Centimeter
• Device Size Text, specify: 0
• Length: 35 Centimeter
• Device Size Text, specify: 0
• Length: 35 Centimeter
• Device Size Text, specify: 0
• Length: 35 Centimeter
• Device Size Text, specify: 0
• Length: 35 Centimeter
• Device Size Text, specify: 0
• Length: 35 Centimeter
• Device Size Text, specify: 0
• Length: 35 Centimeter
• Device Size Text, specify: 0
• Length: 35 Centimeter
• Device Size Text, specify: 0
• Length: 35 Centimeter
• Device Size Text, specify: 0
• Length: 35 Centimeter
• Device Size Text, specify: 0
• Length: 35 Centimeter
• Device Size Text, specify: 0
• Length: 35 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	05037881009742 [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: 2015-10-19

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