Gelweave™ 734028/10ADP

GUDID 05037881121031

Gelweave Gelatin Impregnated Woven Vascular Prosthesis VALSALVA ANTE-FLO

VASCUTEK LTD

Synthetic vascular graft
Primary Device ID05037881121031
NIH Device Record Key86cd236a-eabc-4b8b-83b9-8e2a9d2f4049
Commercial Distribution StatusIn Commercial Distribution
Brand NameGelweave™
Version Model Number734028/10ADP
Catalog Number734028/10ADP
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

Device Dimensions

Length40 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter28 Millimeter
Length40 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter28 Millimeter
Length40 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter28 Millimeter
Length40 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter28 Millimeter
Length40 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter28 Millimeter
Length40 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter28 Millimeter
Length40 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter28 Millimeter
Length40 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter28 Millimeter
Length40 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter28 Millimeter
Length40 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter28 Millimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean dry area. Prosthesis must be implanted within one month after removal from the foil pouch.
Handling Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean dry area. Prosthesis must be implanted within one month after removal from the foil pouch.
Handling Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean dry area. Prosthesis must be implanted within one month after removal from the foil pouch.
Handling Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean dry area. Prosthesis must be implanted within one month after removal from the foil pouch.
Handling Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean dry area. Prosthesis must be implanted within one month after removal from the foil pouch.
Handling Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean dry area. Prosthesis must be implanted within one month after removal from the foil pouch.
Handling Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean dry area. Prosthesis must be implanted within one month after removal from the foil pouch.
Handling Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean dry area. Prosthesis must be implanted within one month after removal from the foil pouch.
Handling Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean dry area. Prosthesis must be implanted within one month after removal from the foil pouch.
Handling Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean dry area. Prosthesis must be implanted within one month after removal from the foil pouch.
Handling Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS105037881121031 [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 [Gelweave™]

05037881999968Gelweave Gelatin Impregnated Woven Vascular Prosthesis 4 BRANCH PLEXUS
05037881999951Gelweave Gelatin Impregnated Woven Vascular Prosthesis 4 BRANCH PLEXUS
05037881999906Gelweave Gelatin Impregnated Woven Vascular Prosthesis ANGLED 4 BRANCH PLEXUS
05037881999579Gelweave Gelatin Impregnated Woven Vascular Prosthesis 4 BRANCH PLEXUS
05037881999432Gelweave Gelatin Impregnated Woven Vascular Prosthesis VALSALVA
05037881999425Gelweave Gelatin Impregnated Woven Vascular Prosthesis VALSALVA
05037881999272Gelweave Gelatin Impregnated Woven Vascular Prosthesis
05037881999265Gelweave Gelatin Impregnated Woven Vascular Prosthesis
05037881998541Gelweave Gelatin Impregnated Woven Vascular Prosthesis Longer Ante-Flo Offset Branch
05037881998527Gelweave Gelatin Impregnated Woven Vascular Prosthesis Longer Ante-Flo Offset Branch
05037881998503Gelweave Gelatin Impregnated Woven Vascular Prosthesis Longer Ante-Flo Offset Branch
05037881998473Gelweave Gelatin Impregnated Woven Vascular Prosthesis 4 BRANCH PLEXUS
05037881998466Gelweave Gelatin Impregnated Woven Vascular Prosthesis 4 BRANCH PLEXUS
05037881998459Gelweave Gelatin Impregnated Woven Vascular Prosthesis 4 BRANCH PLEXUS
05037881998442Gelweave Gelatin Impregnated Woven Vascular Prosthesis SIENA COLLARED 4 BRANCH PLEXUS
05037881998435Gelweave Gelatin Impregnated Woven Vascular Prosthesis 4 BRANCH PLEXUS
05037881998343Gelweave Gelatin Impregnated Woven Vascular Prosthesis PRECURVED 4 BRANCH PLEXUS
05037881998336Gelweave Gelatin Impregnated Woven Vascular Prosthesis PRECURVED 4 BRANCH PLEXUS
05037881998329Gelweave Gelatin Impregnated Woven Vascular Prosthesis PRECURVED 4 BRANCH PLEXUS
05037881998312Gelweave Gelatin Impregnated Woven Vascular Prosthesis PRECURVED 4 BRANCH PLEXUS
05037881998305Gelweave Gelatin Impregnated Woven Vascular Prosthesis PRECURVED 4 BRANCH PLEXUS
05037881998299Gelweave Gelatin Impregnated Woven Vascular Prosthesis PRECURVED 4 BRANCH PLEXUS
05037881998282Gelweave Gelatin Impregnated Woven Vascular Prosthesis PRECURVED 4 BRANCH PLEXUS
05037881998275Gelweave Gelatin Impregnated Woven Vascular Prosthesis PRECURVED 4 BRANCH PLEXUS
05037881998213Gelweave Gelatin Impregnated Woven Vascular Prosthesis VALSALVA
05037881998206Gelweave Gelatin Impregnated Woven Vascular Prosthesis LARGE BORE GELWEAVE
05037881998190Gelweave Gelatin Impregnated Woven Vascular Prosthesis LARGE BORE GELWEAVE
05037881998183Gelweave Gelatin Impregnated Woven Vascular Prosthesis AORTIC ARCH
05037881998169Gelweave Gelatin Impregnated Woven Vascular Prosthesis 4 BRANCH PLEXUS
05037881998077Gelweave Gelatin Impregnated Woven Vascular Prosthesis TRIFURCATE ARCH GRAFT
05037881998060Gelweave Gelatin Impregnated Woven Vascular Prosthesis TRIFURCATE ARCH GRAFT
05037881998053Gelweave Gelatin Impregnated Woven Vascular Prosthesis SIENA COLLARED ANTE-FLO WITH RADIOPAQUE M
05037881998046Gelweave Gelatin Impregnated Woven Vascular Prosthesis SIENA COLLARED ANTE-FLO WITH RADIOPAQUE M
05037881998039Gelweave Gelatin Impregnated Woven Vascular Prosthesis SIENA COLLARED ANTE-FLO WITH RADIOPAQUE M
05037881998022Gelweave Gelatin Impregnated Woven Vascular Prosthesis SIENA COLLARED ANTE-FLO WITH RADIOPAQUE M
05037881998015Gelweave Gelatin Impregnated Woven Vascular Prosthesis SIENA COLLARED ANTE-FLO WITH RADIOPAQUE M
05037881998008Gelweave Gelatin Impregnated Woven Vascular Prosthesis SIENA COLLARED ANTE-FLO WITH RADIOPAQUE M
05037881997995Gelweave Gelatin Impregnated Woven Vascular Prosthesis SIENA COLLARED ANTE-FLO WITH RADIOPAQUE M
05037881997988Gelweave Gelatin Impregnated Woven Vascular Prosthesis SIENA COLLARED ANTE-FLO WITH RADIOPAQUE M
05037881997971Gelweave Gelatin Impregnated Woven Vascular Prosthesis SIENA COLLARED ANTE-FLO WITH RADIOPAQUE M
05037881997964Gelweave Gelatin Impregnated Woven Vascular Prosthesis SIENA COLLARED ANTE-FLO WITH RADIOPAQUE M
05037881997957Gelweave Gelatin Impregnated Woven Vascular Prosthesis SIENA COLLARED ANTE-FLO WITH RADIOPAQUE M
05037881997940Gelweave Gelatin Impregnated Woven Vascular Prosthesis SIENA COLLARED ANTE-FLO WITH RADIOPAQUE M
05037881997933Gelweave Gelatin Impregnated Woven Vascular Prosthesis SIENA COLLARED ANTE-FLO WITH RADIOPAQUE M
05037881997926Gelweave Gelatin Impregnated Woven Vascular Prosthesis SIENA COLLARED ANTE-FLO WITH RADIOPAQUE M
05037881997919Gelweave Gelatin Impregnated Woven Vascular Prosthesis SIENA COLLARED ANTE-FLO WITH RADIOPAQUE M
05037881997902Gelweave Gelatin Impregnated Woven Vascular Prosthesis SIENA COLLARED ANTE-FLO WITH RADIOPAQUE M
05037881997896Gelweave Gelatin Impregnated Woven Vascular Prosthesis SIENA COLLARED 4 BRANCH PLEXUS WITH RADIO
05037881997889Gelweave Gelatin Impregnated Woven Vascular Prosthesis SIENA COLLARED 4 BRANCH PLEXUS
05037881997872Gelweave Gelatin Impregnated Woven Vascular Prosthesis SIENA COLLARED 4 BRANCH PLEXUS

Trademark Results [Gelweave]

Mark Image

Registration | Serial
Company
Trademark
Application Date
GELWEAVE
GELWEAVE
79144456 4705768 Live/Registered
Vascutek Limited
2014-01-17

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