Twillweave™ 531407

GUDID 05037881125664

Twillweave Woven Vascular Prosthesis BIFURCATE

VASCUTEK LTD

Synthetic vascular graft
Primary Device ID05037881125664
NIH Device Record Keyb0d0de7e-87e1-4716-858b-dc8ace60315c
Commercial Distribution StatusIn Commercial Distribution
Brand NameTwillweave™
Version Model Number531407
Catalog Number531407
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
Phone+1(800)262-3304
Emailxx@xx.xx

Device Dimensions

Lumen/Inner Diameter14 Millimeter
Device Size Text, specify0
Length45 Centimeter
Lumen/Inner Diameter14 Millimeter
Device Size Text, specify0
Length45 Centimeter
Lumen/Inner Diameter14 Millimeter
Device Size Text, specify0
Length45 Centimeter
Lumen/Inner Diameter14 Millimeter
Device Size Text, specify0
Length45 Centimeter
Lumen/Inner Diameter14 Millimeter
Device Size Text, specify0
Length45 Centimeter
Lumen/Inner Diameter14 Millimeter
Device Size Text, specify0
Length45 Centimeter
Lumen/Inner Diameter14 Millimeter
Device Size Text, specify0
Length45 Centimeter
Lumen/Inner Diameter14 Millimeter
Device Size Text, specify0
Length45 Centimeter
Lumen/Inner Diameter14 Millimeter
Device Size Text, specify0
Length45 Centimeter
Lumen/Inner Diameter14 Millimeter
Device Size Text, specify0
Length45 Centimeter
Lumen/Inner Diameter14 Millimeter
Device Size Text, specify0
Length45 Centimeter
Lumen/Inner Diameter14 Millimeter
Device Size Text, specify0
Length45 Centimeter
Lumen/Inner Diameter14 Millimeter
Device Size Text, specify0
Length45 Centimeter
Lumen/Inner Diameter14 Millimeter
Device Size Text, specify0
Length45 Centimeter
Lumen/Inner Diameter14 Millimeter
Device Size Text, specify0
Length45 Centimeter
Lumen/Inner Diameter14 Millimeter
Device Size Text, specify0
Length45 Centimeter
Lumen/Inner Diameter14 Millimeter
Device Size Text, specify0
Length45 Centimeter
Lumen/Inner Diameter14 Millimeter
Device Size Text, specify0
Length45 Centimeter
Lumen/Inner Diameter14 Millimeter
Device Size Text, specify0
Length45 Centimeter
Lumen/Inner Diameter14 Millimeter
Device Size Text, specify0
Length45 Centimeter
Lumen/Inner Diameter14 Millimeter
Device Size Text, specify0
Length45 Centimeter
Lumen/Inner Diameter14 Millimeter
Device Size Text, specify0
Length45 Centimeter
Lumen/Inner Diameter14 Millimeter
Device Size Text, specify0
Length45 Centimeter
Lumen/Inner Diameter14 Millimeter
Device Size Text, specify0
Length45 Centimeter
Lumen/Inner Diameter14 Millimeter
Device Size Text, specify0
Length45 Centimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean dry area.
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean dry area.
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean dry area.
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean dry area.
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean dry area.
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean dry area.
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean dry area.
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean dry area.
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean dry area.
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean dry area.
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean dry area.
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean dry area.
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean dry area.
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean dry area.
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean dry area.
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean dry area.
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean dry area.
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean dry area.
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean dry area.
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean dry area.
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean dry area.
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean dry area.
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean dry area.
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean dry area.
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean dry area.
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS105037881125664 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DSYPROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-10-19

On-Brand Devices [Twillweave™]

05037881126159Twillweave Woven Vascular Prosthesis STRAIGHT
05037881126111Twillweave Woven Vascular Prosthesis STRAIGHT
05037881125718Twillweave Woven Vascular Prosthesis BIFURCATE
05037881125701Twillweave Woven Vascular Prosthesis BIFURCATE
05037881125695Twillweave Woven Vascular Prosthesis BIFURCATE
05037881125688Twillweave Woven Vascular Prosthesis BIFURCATE
05037881125671Twillweave Woven Vascular Prosthesis BIFURCATE
05037881125664Twillweave Woven Vascular Prosthesis BIFURCATE
05037881125657Twillweave Woven Vascular Prosthesis BIFURCATE
05037881125596Twillweave Woven Vascular Prosthesis STRAIGHT
05037881125589Twillweave Woven Vascular Prosthesis STRAIGHT
05037881125572Twillweave Woven Vascular Prosthesis STRAIGHT
05037881125565Twillweave Woven Vascular Prosthesis STRAIGHT
05037881125459Twillweave Woven Vascular Prosthesis STRAIGHT
05037881125442Twillweave Woven Vascular Prosthesis STRAIGHT
05037881125282Twillweave Woven Vascular Prosthesis STRAIGHT
05037881125275Twillweave Woven Vascular Prosthesis STRAIGHT
05037881125213Twillweave Woven Vascular Prosthesis STRAIGHT
05037881125206Twillweave Woven Vascular Prosthesis STRAIGHT
05037881125190Twillweave Woven Vascular Prosthesis STRAIGHT
05037881125183Twillweave Woven Vascular Prosthesis STRAIGHT
05037881125060Twillweave Woven Vascular Prosthesis STRAIGHT
05037881125053Twillweave Woven Vascular Prosthesis STRAIGHT
05037881125046Twillweave Woven Vascular Prosthesis STRAIGHT
05037881125039Twillweave Woven Vascular Prosthesis STRAIGHT
05037881125022Twillweave Woven Vascular Prosthesis STRAIGHT
05037881125015Twillweave Woven Vascular Prosthesis STRAIGHT
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