Gelsoft™ 960804

GUDID 05037881010687

Gelsoft Gelatin Impregnated Knitted Cardiovascular Patch

VASCUTEK LTD

Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived
Primary Device ID05037881010687
NIH Device Record Key74293d52-537d-4d04-b358-001e5d5abdaf
Commercial Distribution StatusIn Commercial Distribution
Brand NameGelsoft™
Version Model Number960804
Catalog Number960804
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)888-3786
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)888-3786
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)888-3786
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)888-3786
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)888-3786
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)888-3786
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)888-3786
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)888-3786
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)888-3786
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)888-3786
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)888-3786
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)888-3786
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)888-3786
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)888-3786
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)888-3786
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)888-3786
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)888-3786
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)888-3786
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)888-3786
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)888-3786
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)888-3786
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)888-3786
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)888-3786
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)888-3786
Emailtmccustomer.admin@terumomedical.com

Device Dimensions

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Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in clean, dry area at room temperature. Vascutek Ltd Sealed Patches must be implanted within one month after removal from the foil pouch.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in clean, dry area at room temperature. Vascutek Ltd Sealed Patches must be implanted within one month after removal from the foil pouch.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in clean, dry area at room temperature. Vascutek Ltd Sealed Patches must be implanted within one month after removal from the foil pouch.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in clean, dry area at room temperature. Vascutek Ltd Sealed Patches must be implanted within one month after removal from the foil pouch.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in clean, dry area at room temperature. Vascutek Ltd Sealed Patches must be implanted within one month after removal from the foil pouch.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in clean, dry area at room temperature. Vascutek Ltd Sealed Patches must be implanted within one month after removal from the foil pouch.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in clean, dry area at room temperature. Vascutek Ltd Sealed Patches must be implanted within one month after removal from the foil pouch.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in clean, dry area at room temperature. Vascutek Ltd Sealed Patches must be implanted within one month after removal from the foil pouch.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in clean, dry area at room temperature. Vascutek Ltd Sealed Patches must be implanted within one month after removal from the foil pouch.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in clean, dry area at room temperature. Vascutek Ltd Sealed Patches must be implanted within one month after removal from the foil pouch.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in clean, dry area at room temperature. Vascutek Ltd Sealed Patches must be implanted within one month after removal from the foil pouch.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in clean, dry area at room temperature. Vascutek Ltd Sealed Patches must be implanted within one month after removal from the foil pouch.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in clean, dry area at room temperature. Vascutek Ltd Sealed Patches must be implanted within one month after removal from the foil pouch.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in clean, dry area at room temperature. Vascutek Ltd Sealed Patches must be implanted within one month after removal from the foil pouch.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in clean, dry area at room temperature. Vascutek Ltd Sealed Patches must be implanted within one month after removal from the foil pouch.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in clean, dry area at room temperature. Vascutek Ltd Sealed Patches must be implanted within one month after removal from the foil pouch.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in clean, dry area at room temperature. Vascutek Ltd Sealed Patches must be implanted within one month after removal from the foil pouch.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in clean, dry area at room temperature. Vascutek Ltd Sealed Patches must be implanted within one month after removal from the foil pouch.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in clean, dry area at room temperature. Vascutek Ltd Sealed Patches must be implanted within one month after removal from the foil pouch.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in clean, dry area at room temperature. Vascutek Ltd Sealed Patches must be implanted within one month after removal from the foil pouch.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in clean, dry area at room temperature. Vascutek Ltd Sealed Patches must be implanted within one month after removal from the foil pouch.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in clean, dry area at room temperature. Vascutek Ltd Sealed Patches must be implanted within one month after removal from the foil pouch.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in clean, dry area at room temperature. Vascutek Ltd Sealed Patches must be implanted within one month after removal from the foil pouch.

Device Identifiers

Device Issuing AgencyDevice ID
GS105037881010687 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DXZPATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2020-03-24
Device Publish Date2015-10-22

On-Brand Devices [Gelsoft™]

05037881999463Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis VS040 BIFURCATE WITH SINGLE SIDE BRANCH
05037881999456Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis VS040 BIFURCATE WITH DOUBLE SIDE BRANCHE
05037881999449Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis BIFURCATE
05037881110820Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis BIFURCATE
05037881110813Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis BIFURCATE
05037881110806Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis BIFURCATE
05037881110790Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis BIFURCATE
05037881110783Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis BIFURCATE
05037881110776Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis AX-BIFEM EQUI-FLO ERS REINFORCED
05037881110769Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis AX-BIFEM EQUI-FLO ERS REINFORCED
05037881110752Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis AX-BIFEM EQUI-FLO ERS REINFORCED
05037881110738Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis AX-BIFEM EQUI-FLO ERS REINFORCED
05037881110721Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis AX-BIFEM EQUI-FLO ERS REINFORCED
05037881110714Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis AX-BIFEM EQUI-FLO ERS REINFORCED
05037881110707Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis AX-BIFEM ERS REINFORCED
05037881110691Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis AX-BIFEM ERS REINFORCED
05037881110684Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis FEM-FEM ERS CENTRALLY REINFORCED
05037881110677Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis FEM-FEM ERS CENTRALLY REINFORCED
05037881110660Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis FEM-FEM ERS CENTRALLY REINFORCED
05037881110653Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis FEM-FEM ERS CENTRALLY REINFORCED
05037881110646Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis STRAIGHT ERS REINFORCED
05037881110639Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis STRAIGHT ERS REINFORCED
05037881110622Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis STRAIGHT ERS REINFORCED
05037881110615Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis STRAIGHT ERS REINFORCED
05037881110608Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis STRAIGHT ERS REINFORCED
05037881110585Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis AX-BIFEM RIGHT BRANCH
05037881110578Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis AX-BIFEM LEFT BRANCH
05037881110561Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis AX-BIFEM RIGHT BRANCH
05037881110554Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis AX-BIFEM LEFT BRANCH
05037881110547Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis AX-BIFEM RIGHT BRANCH
05037881110530Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis STRAIGHT
05037881110523Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis STRAIGHT
05037881110516Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis STRAIGHT
05037881110509Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis BIFURCATE
05037881110493Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis BIFURCATE
05037881110486Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis BIFURCATE
05037881110479Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis BIFURCATE
05037881110462Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis BIFURCATE
05037881110455Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis BIFURCATE
05037881110448Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis BIFURCATE
05037881110431Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis STRAIGHT
05037881110424Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis STRAIGHT
05037881110417Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis STRAIGHT
05037881110400Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis STRAIGHT
05037881110394Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis STRAIGHT
05037881110387Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis STRAIGHT
05037881110370Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis STRAIGHT
05037881110363Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis STRAIGHT
05037881110356Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis STRAIGHT
05037881110349Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis STRAIGHT

Trademark Results [Gelsoft]

Mark Image

Registration | Serial
Company
Trademark
Application Date
GELSOFT
GELSOFT
79311848 not registered Live/Pending
CLARK CFP PTY LTD
2021-03-04
GELSOFT
GELSOFT
79298177 not registered Live/Pending
DNA LEISURE HOLDINGS LIMITED
2020-09-04
GELSOFT
GELSOFT
79160115 4887242 Live/Registered
Vascutek Limited
2014-10-02

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