SealPTFE™ S4005S

GUDID 05037881002750

SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Standard Wall

VASCUTEK LTD

Synthetic vascular graft

• Primary Device ID: 05037881002750
• NIH Device Record Key: fe6393cb-2b10-484f-8f6c-a1457c4c6efd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SealPTFE™
• Version Model Number: S4005S
• Catalog Number: S4005S
• 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: 5 Millimeter
• Length: 40 Centimeter
• Lumen/Inner Diameter: 5 Millimeter
• Length: 40 Centimeter
• Lumen/Inner Diameter: 5 Millimeter
• Length: 40 Centimeter
• Lumen/Inner Diameter: 5 Millimeter
• Length: 40 Centimeter
• Lumen/Inner Diameter: 5 Millimeter
• Length: 40 Centimeter
• Lumen/Inner Diameter: 5 Millimeter
• Length: 40 Centimeter
• Lumen/Inner Diameter: 5 Millimeter
• Length: 40 Centimeter
• Lumen/Inner Diameter: 5 Millimeter
• Length: 40 Centimeter
• Lumen/Inner Diameter: 5 Millimeter
• Length: 40 Centimeter
• Lumen/Inner Diameter: 5 Millimeter
• Length: 40 Centimeter
• Lumen/Inner Diameter: 5 Millimeter
• Length: 40 Centimeter
• Lumen/Inner Diameter: 5 Millimeter
• Length: 40 Centimeter
• Lumen/Inner Diameter: 5 Millimeter
• Length: 40 Centimeter
• Lumen/Inner Diameter: 5 Millimeter
• Length: 40 Centimeter
• Lumen/Inner Diameter: 5 Millimeter
• Length: 40 Centimeter
• Lumen/Inner Diameter: 5 Millimeter
• Length: 40 Centimeter
• Lumen/Inner Diameter: 5 Millimeter
• Length: 40 Centimeter
• Lumen/Inner Diameter: 5 Millimeter
• Length: 40 Centimeter
• Lumen/Inner Diameter: 5 Millimeter
• Length: 40 Centimeter
• Lumen/Inner Diameter: 5 Millimeter
• Length: 40 Centimeter
• Lumen/Inner Diameter: 5 Millimeter
• Length: 40 Centimeter
• Lumen/Inner Diameter: 5 Millimeter
• Length: 40 Centimeter
• Lumen/Inner Diameter: 5 Millimeter
• Length: 40 Centimeter
• Lumen/Inner Diameter: 5 Millimeter
• Length: 40 Centimeter
• Lumen/Inner Diameter: 5 Millimeter
• Length: 40 Centimeter

Operating and Storage Conditions

• Handling Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean dry area. Do not expose ePTFE products to temperature greater than 500°F (260 °C).
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean dry area. Do not expose ePTFE products to temperature greater than 500°F (260 °C).
• Handling Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean dry area. Do not expose ePTFE products to temperature greater than 500°F (260 °C).
• Handling Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean dry area. Do not expose ePTFE products to temperature greater than 500°F (260 °C).
• Handling Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean dry area. Do not expose ePTFE products to temperature greater than 500°F (260 °C).
• Handling Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean dry area. Do not expose ePTFE products to temperature greater than 500°F (260 °C).
• Handling Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean dry area. Do not expose ePTFE products to temperature greater than 500°F (260 °C).
• Handling Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean dry area. Do not expose ePTFE products to temperature greater than 500°F (260 °C).
• Handling Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean dry area. Do not expose ePTFE products to temperature greater than 500°F (260 °C).
• Handling Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean dry area. Do not expose ePTFE products to temperature greater than 500°F (260 °C).
• Handling Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean dry area. Do not expose ePTFE products to temperature greater than 500°F (260 °C).
• Handling Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean dry area. Do not expose ePTFE products to temperature greater than 500°F (260 °C).
• Handling Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean dry area. Do not expose ePTFE products to temperature greater than 500°F (260 °C).
• Handling Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean dry area. Do not expose ePTFE products to temperature greater than 500°F (260 °C).
• Handling Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean dry area. Do not expose ePTFE products to temperature greater than 500°F (260 °C).
• Handling Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean dry area. Do not expose ePTFE products to temperature greater than 500°F (260 °C).
• Handling Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean dry area. Do not expose ePTFE products to temperature greater than 500°F (260 °C).
• Handling Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean dry area. Do not expose ePTFE products to temperature greater than 500°F (260 °C).
• Handling Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean dry area. Do not expose ePTFE products to temperature greater than 500°F (260 °C).
• Handling Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean dry area. Do not expose ePTFE products to temperature greater than 500°F (260 °C).
• Handling Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean dry area. Do not expose ePTFE products to temperature greater than 500°F (260 °C).
• Handling Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean dry area. Do not expose ePTFE products to temperature greater than 500°F (260 °C).
• Handling Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean dry area. Do not expose ePTFE products to temperature greater than 500°F (260 °C).
• Handling Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean dry area. Do not expose ePTFE products to temperature greater than 500°F (260 °C).
• Handling Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean dry area. Do not expose ePTFE products to temperature greater than 500°F (260 °C).
• Handling Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05037881002750 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K043552

FDA Product Code

• MAL: GRAFT, VASCULAR, SYNTHETIC/BIOLOGIC COMPOSITE

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 [SealPTFE™]

• 05037881999173: SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Thin Wall Straight with Central Support
• 05037881153292: SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Ultrathin Wall Straight Wrapped FULLY REINFORC
• 05037881153285: SEALPTFE Wrap with Unity Construction Gelatin Sealed ePTFE Vascular Prosthesis Ultrathin Wall St
• 05037881153278: SEALPTFE Wrap with Unity Construction Gelatin Sealed ePTFE Vascular Prosthesis Ultrathin Wall St
• 05037881153261: SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Ultrathin Wall Straight Wrapped FULLY REINFORC
• 05037881153247: SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Ultrathin Wall Straight Wrapped FULLY REINFORC
• 05037881153230: SEALPTFE Wrap with Unity Construction Gelatin Sealed ePTFE Vascular Prosthesis Ultrathin Wall St
• 05037881153223: SEALPTFE Wrap with Unity Construction Gelatin Sealed ePTFE Vascular Prosthesis Ultrathin Wall St
• 05037881153216: SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Ultrathin Wall Straight Wrapped FULLY REINFORC
• 05037881153193: SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Ultrathin Wall Straight Wrapped FULLY REINFORC
• 05037881153186: SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Ultrathin Wall Straight Wrapped FULLY REINFORC
• 05037881153179: SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Ultrathin Wall Straight Wrapped FULLY REINFORC
• 05037881153162: SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Ultrathin Wall Straight Wrapped FULLY REINFORC
• 05037881153148: SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Ultrathin Wall Straight Wrapped FULLY REINFORC
• 05037881153131: SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Ultrathin Wall Straight Wrapped FULLY REINFORC
• 05037881153124: SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Ultrathin Wall Straight Wrapped FULLY REINFORC
• 05037881153117: SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Ultrathin Wall Straight Wrapped FULLY REINFORC
• 05037881153094: SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Ultrathin Wall Straight Wrapped FULLY REINFORC
• 05037881153087: SEALPTFE Wrap with Unity Construction Gelatin Sealed ePTFE Vascular Prosthesis Ultrathin Wall St
• 05037881153070: SEALPTFE Wrap with Unity Construction Gelatin Sealed ePTFE Vascular Prosthesis Ultrathin Wall St
• 05037881153063: SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Ultrathin Wall Straight Wrapped FULLY REINFORC
• 05037881153056: SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Ultrathin Wall Straight Wrapped FULLY REINFORC
• 05037881153032: SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Ultrathin Wall Straight Wrapped FULLY REINFORC
• 05037881153025: SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Ultrathin Wall Straight Wrapped FULLY REINFORC
• 05037881153018: SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Ultrathin Wall Straight Wrapped FULLY REINFORC
• 05037881152981: SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Ultrathin Wall Straight Wrapped FULLY REINFORC
• 05037881152974: SEALPTFE Wrap with Unity Construction Gelatin Sealed ePTFE Vascular Prosthesis Ultrathin Wall St
• 05037881152967: SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Ultrathin Wall Straight Wrapped FULLY REINFORC
• 05037881152943: SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Ultrathin Wall Straight Wrapped FULLY REINFORC
• 05037881152936: SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Ultrathin Wall Straight Wrapped FULLY REINFORC
• 05037881152929: SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Ultrathin Wall Straight Wrapped FULLY REINFORC
• 05037881152899: SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Standard Wall Straight WrappedFULLY REINFORCED
• 05037881152882: SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Standard Wall Straight WrappedFULLY REINFORCED
• 05037881152875: SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Standard Wall Straight WrappedFULLY REINFORCED
• 05037881152868: SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Standard Wall Straight WrappedFULLY REINFORCED
• 05037881152844: SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Standard Wall Straight WrappedFULLY REINFORCED
• 05037881152837: SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Standard Wall Straight WrappedFULLY REINFORCED
• 05037881152820: SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Standard Wall Straight WrappedFULLY REINFORCED
• 05037881152813: SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Standard Wall Straight WrappedFULLY REINFORCED
• 05037881152806: SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Standard Wall Straight WrappedFULLY REINFORCED
• 05037881152790: SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Standard Wall Straight WrappedFULLY REINFORCED
• 05037881152783: SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Standard Wall Straight WrappedFULLY REINFORCED
• 05037881152776: SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Standard Wall Straight WrappedFULLY REINFORCED
• 05037881152769: SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Standard Wall Straight WrappedFULLY REINFORCED
• 05037881152752: SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Standard Wall Straight WrappedFULLY REINFORCED
• 05037881152745: SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Standard Wall Straight WrappedFULLY REINFORCED
• 05037881152738: SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Standard Wall Straight WrappedFULLY REINFORCED
• 05037881152721: SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Standard Wall Straight WrappedFULLY REINFORCED
• 05037881152714: SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Standard Wall Straight WrappedFULLY REINFORCED
• 05037881152691: SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Standard Wall Straight WrappedFULLY REINFORCED