VP1200K™ 321218

GUDID 05037881020426

VP1200K Knitted Vascular Prosthesis STRAIGHT

VASCUTEK LTD

Synthetic vascular graft
Primary Device ID05037881020426
NIH Device Record Key948a56ba-a87e-4728-b050-fda232d02138
Commercial Distribution StatusIn Commercial Distribution
Brand NameVP1200K™
Version Model Number321218
Catalog Number321218
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 Diameter18 Millimeter
Lumen/Inner Diameter18 Millimeter
Lumen/Inner Diameter18 Millimeter
Lumen/Inner Diameter18 Millimeter
Lumen/Inner Diameter18 Millimeter
Lumen/Inner Diameter18 Millimeter
Lumen/Inner Diameter18 Millimeter
Lumen/Inner Diameter18 Millimeter
Lumen/Inner Diameter18 Millimeter
Lumen/Inner Diameter18 Millimeter
Lumen/Inner Diameter18 Millimeter
Lumen/Inner Diameter18 Millimeter
Lumen/Inner Diameter18 Millimeter
Lumen/Inner Diameter18 Millimeter
Lumen/Inner Diameter18 Millimeter
Lumen/Inner Diameter18 Millimeter
Lumen/Inner Diameter18 Millimeter
Lumen/Inner Diameter18 Millimeter
Lumen/Inner Diameter18 Millimeter
Lumen/Inner Diameter18 Millimeter
Lumen/Inner Diameter18 Millimeter
Lumen/Inner Diameter18 Millimeter
Lumen/Inner Diameter18 Millimeter
Lumen/Inner Diameter18 Millimeter
Lumen/Inner Diameter18 Millimeter

Operating and Storage Conditions

Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean dry area
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
GS105037881020426 [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 [VP1200K™]

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