Gelseal™ 951010

GUDID 05037881010427

Gelseal 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 ID05037881010427
NIH Device Record Key2b15e1f3-e037-4a20-a1e0-c83621d86805
Commercial Distribution StatusIn Commercial Distribution
Brand NameGelseal™
Version Model Number951010
Catalog Number951010
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)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

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

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
GS105037881010427 [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 Number4
Public Version Date2019-02-19
Device Publish Date2015-10-22

On-Brand Devices [Gelseal™]

05037881101330Gelseal Gelatin Impregnated Knitted Vascular Prosthesis STRAIGHT
05037881101262Gelseal Gelatin Impregnated Knitted Vascular Prosthesis STRAIGHT ERT REINFORCED
05037881101255Gelseal Gelatin Impregnated Knitted Vascular Prosthesis STRAIGHT ERT REINFORCED
05037881101248Gelseal Gelatin Impregnated Knitted Vascular Prosthesis STRAIGHT ERT REINFORCED
05037881101231Gelseal Gelatin Impregnated Knitted Vascular Prosthesis STRAIGHT ERT REINFORCED
05037881101224Gelseal Gelatin Impregnated Knitted Vascular Prosthesis STRAIGHT ERT REINFORCED
05037881101194Gelseal Gelatin Impregnated Knitted Vascular Prosthesis AX-BIFEM LEFT BRANCH
05037881101118Gelseal Gelatin Impregnated Knitted Vascular Prosthesis
05037881101064Gelseal Gelatin Impregnated Knitted Vascular Prosthesis
05037881101057Gelseal Gelatin Impregnated Knitted Vascular Prosthesis
05037881101002Gelseal Gelatin Impregnated Knitted Vascular Prosthesis
05037881100999Gelseal Gelatin Impregnated Knitted Vascular Prosthesis 4 BRANCH PLEXUS
05037881100982Gelseal Gelatin Impregnated Knitted Vascular Prosthesis
05037881100975Gelseal Gelatin Impregnated Knitted Vascular Prosthesis
05037881100968Gelseal Gelatin Impregnated Knitted Vascular Prosthesis 4 BRANCH PLEXUS
05037881100951Gelseal Gelatin Impregnated Knitted Vascular Prosthesis
05037881100944Gelseal Gelatin Impregnated Knitted Vascular Prosthesis
05037881100937Gelseal Gelatin Impregnated Knitted Vascular Prosthesis 4 BRANCH PLEXUS
05037881100920Gelseal Gelatin Impregnated Knitted Vascular Prosthesis
05037881100913Gelseal Gelatin Impregnated Knitted Vascular Prosthesis
05037881100906Gelseal Gelatin Impregnated Knitted Vascular Prosthesis
05037881100890Gelseal Gelatin Impregnated Knitted Vascular Prosthesis
05037881100883Gelseal Gelatin Impregnated Knitted Vascular Prosthesis 3 BRANCH PLEXUS
05037881100876Gelseal Gelatin Impregnated Knitted Vascular Prosthesis
05037881100869Gelseal Gelatin Impregnated Knitted Vascular Prosthesis
05037881100852Gelseal Gelatin Impregnated Knitted Vascular Prosthesis
05037881100821Gelseal Gelatin Impregnated Knitted Vascular Prosthesis
05037881100685Gelseal Gelatin Impregnated Knitted Vascular Prosthesis ANTE-FLO
05037881100678Gelseal Gelatin Impregnated Knitted Vascular Prosthesis ANTE-FLO
05037881100661Gelseal Gelatin Impregnated Knitted Vascular Prosthesis ANTE-FLO
05037881100654Gelseal Gelatin Impregnated Knitted Vascular Prosthesis ANTE-FLO
05037881100647Gelseal Gelatin Impregnated Knitted Vascular Prosthesis
05037881100630Gelseal Gelatin Impregnated Knitted Vascular Prosthesis
05037881100623Gelseal Gelatin Impregnated Knitted Vascular Prosthesis ANTE-FLO
05037881100616Gelseal Gelatin Impregnated Knitted Vascular Prosthesis ANTE-FLO
05037881100609Gelseal Gelatin Impregnated Knitted Vascular Prosthesis ANTE-FLO
05037881100593Gelseal Gelatin Impregnated Knitted Vascular Prosthesis ANTE-FLO
05037881100586Gelseal Gelatin Impregnated Knitted Vascular Prosthesis ANTE-FLO
05037881100579Gelseal Gelatin Impregnated Knitted Vascular Prosthesis
05037881100562Gelseal Gelatin Impregnated Knitted Vascular Prosthesis BIFURCATE
05037881100555Gelseal Gelatin Impregnated Knitted Vascular Prosthesis BIFURCATE
05037881100548Gelseal Gelatin Impregnated Knitted Vascular Prosthesis BIFURCATE
05037881100531Gelseal Gelatin Impregnated Knitted Vascular Prosthesis BIFURCATE
05037881100524Gelseal Gelatin Impregnated Knitted Vascular Prosthesis BIFURCATE
05037881100517Gelseal Gelatin Impregnated Knitted Vascular Prosthesis BIFURCATE
05037881100500Gelseal Gelatin Impregnated Knitted Vascular Prosthesis 4 BRANCH PLEXUS
05037881100494Gelseal Gelatin Impregnated Knitted Vascular Prosthesis BIFURCATE
05037881100487Gelseal Gelatin Impregnated Knitted Vascular Prosthesis STRAIGHT
05037881100470Gelseal Gelatin Impregnated Knitted Vascular Prosthesis STRAIGHT
05037881100463Gelseal Gelatin Impregnated Knitted Vascular Prosthesis STRAIGHT

Trademark Results [Gelseal]

Mark Image

Registration | Serial
Company
Trademark
Application Date
GELSEAL
GELSEAL
86278054 not registered Dead/Abandoned
Connolly, Phillip
2014-05-12
GELSEAL
GELSEAL
85359435 4240184 Live/Registered
Applied Medical Resources Corporation
2011-06-29
GELSEAL
GELSEAL
85010606 not registered Dead/Abandoned
TYR Sport, Inc.
2010-04-09
GELSEAL
GELSEAL
79161619 5173434 Live/Registered
Vascutek Limited
2014-10-02
GELSEAL
GELSEAL
78777862 3201179 Dead/Cancelled
WELCH ALLYN, INC.
2005-12-21
GELSEAL
GELSEAL
76333044 2843520 Dead/Cancelled
APPLIED MEDICAL RESOURCES CORPORATION
2001-11-01
GELSEAL
GELSEAL
75936741 not registered Dead/Abandoned
Banner Pharmacaps, Inc.
2000-03-06

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.