Thinwall 921010T

GUDID 05037881010854

Thin Wall Carotid Patch Gelatin Impregnated Thin Wall Knitted Carotid Patch TAPERED 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 ID05037881010854
NIH Device Record Key7fbaa0c7-98aa-4b33-be67-925d5b66be55
Commercial Distribution StatusIn Commercial Distribution
Brand NameThinwall
Version Model Number921010T
Catalog Number921010T
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

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. 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.
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
GS105037881010854 [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 [Thinwall]

05037881999227Thin Wall Carotid Patch Gelatin Impregnated Thin Wall Knitted Carotid Patch TAPERED NO BLACK LIN
05037881010892Thin Wall Carotid Patch Gelatin Impregnated Thin Wall Knitted Carotid Patch TAPERED PATCH
05037881010885Thin Wall Carotid Patch Gelatin Impregnated Thin Wall Knitted Carotid Patch TAPERED PATCH
05037881010878Thin Wall Carotid Patch Gelatin Impregnated Thin Wall Knitted Carotid Patch TAPERED PATCH
05037881010861Thin Wall Carotid Patch Gelatin Impregnated Thin Wall Knitted Carotid Patch TAPERED PATCH
05037881010854Thin Wall Carotid Patch Gelatin Impregnated Thin Wall Knitted Carotid Patch TAPERED PATCH
05037881010847Thin Wall Carotid Patch Gelatin Impregnated Thin Wall Knitted Carotid Patch TAPERED PATCH
05037881010830Thin Wall Carotid Patch Gelatin Impregnated Thin Wall Knitted Carotid Patch TAPERED PATCH
05037881010823Thin Wall Carotid Patch Gelatin Impregnated Thin Wall Knitted Carotid Patch TAPERED PATCH
05037881010816Thin Wall Carotid Patch Gelatin Impregnated Thin Wall Knitted Carotid Patch TAPERED PATCH

Trademark Results [Thinwall]

Mark Image

Registration | Serial
Company
Trademark
Application Date
THINWALL
THINWALL
72274986 0865964 Dead/Expired
PRECISION PAPER TUBE COMPANY
1967-06-28
THINWALL
THINWALL
72257744 0843957 Dead/Expired
ADANLOCK JAMESTOWN CORPORATION
1966-11-02

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