SealPTFE™ T3005S

GUDID 05037881002903

SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Ultrathin

VASCUTEK LTD

Synthetic vascular graft
Primary Device ID05037881002903
NIH Device Record Keyb7d3cc3a-1738-4b42-ab08-828858500a61
Commercial Distribution Discontinuation2019-03-30
Commercial Distribution StatusNot in Commercial Distribution
Brand NameSealPTFE™
Version Model NumberT3005S
Catalog NumberT3005S
Company DUNS229053087
Company NameVASCUTEK LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)262-3304
Emailxx@xx.xx
Phone+1(800)262-3304
Emailxx@xx.xx
Phone+1(800)262-3304
Emailxx@xx.xx
Phone+1(800)262-3304
Emailxx@xx.xx
Phone+1(800)262-3304
Emailxx@xx.xx
Phone+1(800)262-3304
Emailxx@xx.xx
Phone+1(800)262-3304
Emailxx@xx.xx
Phone+1(800)262-3304
Emailxx@xx.xx
Phone+1(800)262-3304
Emailxx@xx.xx
Phone+1(800)262-3304
Emailxx@xx.xx
Phone+1(800)262-3304
Emailxx@xx.xx
Phone+1(800)262-3304
Emailxx@xx.xx
Phone+1(800)262-3304
Emailxx@xx.xx
Phone+1(800)262-3304
Emailxx@xx.xx
Phone+1(800)262-3304
Emailxx@xx.xx
Phone+1(800)262-3304
Emailxx@xx.xx
Phone+1(800)262-3304
Emailxx@xx.xx
Phone+1(800)262-3304
Emailxx@xx.xx
Phone+1(800)262-3304
Emailxx@xx.xx
Phone+1(800)262-3304
Emailxx@xx.xx
Phone+1(800)262-3304
Emailxx@xx.xx
Phone+1(800)262-3304
Emailxx@xx.xx
Phone+1(800)262-3304
Emailxx@xx.xx
Phone+1(800)262-3304
Emailxx@xx.xx

Device Dimensions

Lumen/Inner Diameter5 Millimeter
Length30 Centimeter
Lumen/Inner Diameter5 Millimeter
Length30 Centimeter
Lumen/Inner Diameter5 Millimeter
Length30 Centimeter
Lumen/Inner Diameter5 Millimeter
Length30 Centimeter
Lumen/Inner Diameter5 Millimeter
Length30 Centimeter
Lumen/Inner Diameter5 Millimeter
Length30 Centimeter
Lumen/Inner Diameter5 Millimeter
Length30 Centimeter
Lumen/Inner Diameter5 Millimeter
Length30 Centimeter
Lumen/Inner Diameter5 Millimeter
Length30 Centimeter
Lumen/Inner Diameter5 Millimeter
Length30 Centimeter
Lumen/Inner Diameter5 Millimeter
Length30 Centimeter
Lumen/Inner Diameter5 Millimeter
Length30 Centimeter
Lumen/Inner Diameter5 Millimeter
Length30 Centimeter
Lumen/Inner Diameter5 Millimeter
Length30 Centimeter
Lumen/Inner Diameter5 Millimeter
Length30 Centimeter
Lumen/Inner Diameter5 Millimeter
Length30 Centimeter
Lumen/Inner Diameter5 Millimeter
Length30 Centimeter
Lumen/Inner Diameter5 Millimeter
Length30 Centimeter
Lumen/Inner Diameter5 Millimeter
Length30 Centimeter
Lumen/Inner Diameter5 Millimeter
Length30 Centimeter
Lumen/Inner Diameter5 Millimeter
Length30 Centimeter
Lumen/Inner Diameter5 Millimeter
Length30 Centimeter
Lumen/Inner Diameter5 Millimeter
Length30 Centimeter
Lumen/Inner Diameter5 Millimeter
Length30 Centimeter

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS105037881002903 [Primary]

FDA Product Code

MALGRAFT, VASCULAR, SYNTHETIC/BIOLOGIC COMPOSITE

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2021-01-20
Device Publish Date2015-10-19

On-Brand Devices [SealPTFE™]

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