VP1200K™ 251010

GUDID 05037881020051

VP1200KAX-BIFEM RIGHT

VASCUTEK LTD

Synthetic vascular graft

• Primary Device ID: 05037881020051
• NIH Device Record Key: 8b28f7d7-82e6-441a-b242-d0c28e9c727f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VP1200K™
• Version Model Number: 251010
• Catalog Number: 251010
• 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)262-3304
• Email: xx@xx.xx
• Phone: +1(800)262-3304
• Email: xx@xx.xx
• Phone: +1(800)262-3304
• Email: xx@xx.xx
• Phone: +1(800)262-3304
• Email: xx@xx.xx
• Phone: +1(800)262-3304
• Email: xx@xx.xx
• Phone: +1(800)262-3304
• Email: xx@xx.xx
• Phone: +1(800)262-3304
• Email: xx@xx.xx
• Phone: +1(800)262-3304
• Email: xx@xx.xx
• Phone: +1(800)262-3304
• Email: xx@xx.xx
• Phone: +1(800)262-3304
• Email: xx@xx.xx
• Phone: +1(800)262-3304
• Email: xx@xx.xx
• Phone: +1(800)262-3304
• Email: xx@xx.xx
• Phone: +1(800)262-3304
• Email: xx@xx.xx
• Phone: +1(800)262-3304
• Email: xx@xx.xx
• Phone: +1(800)262-3304
• Email: xx@xx.xx
• Phone: +1(800)262-3304
• Email: xx@xx.xx
• Phone: +1(800)262-3304
• Email: xx@xx.xx
• Phone: +1(800)262-3304
• Email: xx@xx.xx
• Phone: +1(800)262-3304
• Email: xx@xx.xx
• Phone: +1(800)262-3304
• Email: xx@xx.xx
• Phone: +1(800)262-3304
• Email: xx@xx.xx
• Phone: +1(800)262-3304
• Email: xx@xx.xx
• Phone: +1(800)262-3304
• Email: xx@xx.xx
• Phone: +1(800)262-3304
• Email: xx@xx.xx
• Phone: +1(800)262-3304
• Email: xx@xx.xx

Device Dimensions

• Lumen/Inner Diameter: 10 Millimeter
• Length: 100 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 10 Millimeter
• Length: 100 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 10 Millimeter
• Length: 100 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 10 Millimeter
• Length: 100 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 10 Millimeter
• Length: 100 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 10 Millimeter
• Length: 100 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 10 Millimeter
• Length: 100 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 10 Millimeter
• Length: 100 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 10 Millimeter
• Length: 100 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 10 Millimeter
• Length: 100 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 10 Millimeter
• Length: 100 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 10 Millimeter
• Length: 100 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 10 Millimeter
• Length: 100 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 10 Millimeter
• Length: 100 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 10 Millimeter
• Length: 100 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 10 Millimeter
• Length: 100 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 10 Millimeter
• Length: 100 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 10 Millimeter
• Length: 100 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 10 Millimeter
• Length: 100 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 10 Millimeter
• Length: 100 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 10 Millimeter
• Length: 100 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 10 Millimeter
• Length: 100 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 10 Millimeter
• Length: 100 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 10 Millimeter
• Length: 100 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 10 Millimeter
• Length: 100 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean dry area
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean dry area
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean dry area
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean dry area
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean dry area
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean dry area
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean dry area
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean dry area
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean dry area
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean dry area
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean dry area
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean dry area
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean dry area
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean dry area
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean dry area
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean dry area
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean dry area
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean dry area
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean dry area
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean dry area
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean dry area
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean dry area
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean dry area
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean dry area
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean dry area
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05037881020051 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K034010

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-10-19

On-Brand Devices [VP1200K™]

• 05037881020556: VP1200K Knitted Vascular Prosthesis STRAIGHT
• 05037881020549: VP1200K Knitted Vascular Prosthesis STRAIGHT
• 05037881020532: VP1200K Knitted Vascular Prosthesis STRAIGHT
• 05037881020495: VP1200K Knitted Vascular Prosthesis BIFURCATE
• 05037881020488: VP1200K Knitted Vascular Prosthesis BIFURCATE
• 05037881020471: VP1200K Knitted Vascular Prosthesis BIFURCATE
• 05037881020457: VP1200K Knitted Vascular Prosthesis STRAIGHT
• 05037881020440: VP1200K Knitted Vascular Prosthesis STRAIGHT
• 05037881020433: VP1200K Knitted Vascular Prosthesis STRAIGHT
• 05037881020426: VP1200K Knitted Vascular Prosthesis STRAIGHT
• 05037881020419: VP1200K Knitted Vascular Prosthesis STRAIGHT
• 05037881020402: VP1200K Knitted Vascular Prosthesis STRAIGHT
• 05037881020396: VP1200K Knitted Vascular Prosthesis STRAIGHT
• 05037881020389: VP1200K Knitted Vascular Prosthesis STRAIGHT
• 05037881020372: VP1200K Knitted Vascular Prosthesis STRAIGHT
• 05037881020365: VP1200K Knitted Vascular Prosthesis STRAIGHT
• 05037881020358: VP1200K Knitted Vascular Prosthesis STRAIGHT
• 05037881020341: VP1200K Knitted Vascular Prosthesis STRAIGHT
• 05037881020334: VP1200K Knitted Vascular Prosthesis STRAIGHT
• 05037881020327: VP1200K Knitted Vascular Prosthesis STRAIGHT
• 05037881020303: VP1200K Knitted Vascular Prosthesis STRAIGHT
• 05037881020297: VP1200K Knitted Vascular Prosthesis STRAIGHT
• 05037881020280: VP1200K Knitted Vascular Prosthesis STRAIGHT
• 05037881020273: VP1200K Knitted Vascular Prosthesis STRAIGHT
• 05037881020266: VP1200K Knitted Vascular Prosthesis STRAIGHT
• 05037881020259: VP1200K Knitted Vascular Prosthesis STRAIGHT
• 05037881020242: VP1200K Knitted Vascular Prosthesis STRAIGHT
• 05037881020235: VP1200K Knitted Vascular Prosthesis STRAIGHT
• 05037881020228: VP1200K Knitted Vascular Prosthesis STRAIGHT
• 05037881020211: VP1200K Knitted Vascular Prosthesis STRAIGHT
• 05037881020204: VP1200K Knitted Vascular Prosthesis STRAIGHT
• 05037881020181: VP1200K STRAIGHT REINFORCED
• 05037881020174: VP1200K STRAIGHT REINFORCED
• 05037881020136: VP1200K STRAIGHT REINFORCED
• 05037881020051: VP1200KAX-BIFEM RIGHT
• 05037881020044: VP1200K AX-BIFEM LEFT
• 05037881020020: VP1200K Knitted Vascular Prosthesis STRAIGHT
• 05037881020013: VP1200K Knitted Vascular Prosthesis STRAIGHT