Parietex TCM1515X3

GUDID 20884521178882

Lightweight Mesh,Monofilament Polyester

Covidien LP

Abdominal hernia surgical mesh, synthetic polymer, non-bioabsorbable
Primary Device ID20884521178882
NIH Device Record Key620bf894-148d-4aba-a722-3626d6d9fab4
Commercial Distribution Discontinuation2019-10-21
Commercial Distribution StatusNot in Commercial Distribution
Brand NameParietex
Version Model NumberTCM1515X3
Catalog NumberTCM1515X3
Company DUNS058614483
Company NameCovidien LP
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 Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com

Device Dimensions

Width15 Centimeter
Length15 Centimeter
Width15 Centimeter
Length15 Centimeter
Width15 Centimeter
Length15 Centimeter
Width15 Centimeter
Length15 Centimeter
Width15 Centimeter
Length15 Centimeter
Width15 Centimeter
Length15 Centimeter
Width15 Centimeter
Length15 Centimeter
Width15 Centimeter
Length15 Centimeter
Width15 Centimeter
Length15 Centimeter
Width15 Centimeter
Length15 Centimeter
Width15 Centimeter
Length15 Centimeter
Width15 Centimeter
Length15 Centimeter
Width15 Centimeter
Length15 Centimeter
Width15 Centimeter
Length15 Centimeter
Width15 Centimeter
Length15 Centimeter
Width15 Centimeter
Length15 Centimeter
Width15 Centimeter
Length15 Centimeter
Width15 Centimeter
Length15 Centimeter
Width15 Centimeter
Length15 Centimeter
Width15 Centimeter
Length15 Centimeter
Width15 Centimeter
Length15 Centimeter
Width15 Centimeter
Length15 Centimeter
Width15 Centimeter
Length15 Centimeter
Width15 Centimeter
Length15 Centimeter
Width15 Centimeter
Length15 Centimeter
Width15 Centimeter
Length15 Centimeter
Width15 Centimeter
Length15 Centimeter
Width15 Centimeter
Length15 Centimeter
Width15 Centimeter
Length15 Centimeter
Width15 Centimeter
Length15 Centimeter
Width15 Centimeter
Length15 Centimeter
Width15 Centimeter
Length15 Centimeter
Width15 Centimeter
Length15 Centimeter
Width15 Centimeter
Length15 Centimeter
Width15 Centimeter
Length15 Centimeter
Width15 Centimeter
Length15 Centimeter
Width15 Centimeter
Length15 Centimeter
Width15 Centimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *;
Special Storage Condition, SpecifyBetween 0 and 0 *;
Special Storage Condition, SpecifyBetween 0 and 0 *;
Special Storage Condition, SpecifyBetween 0 and 0 *;
Special Storage Condition, SpecifyBetween 0 and 0 *;
Special Storage Condition, SpecifyBetween 0 and 0 *;
Special Storage Condition, SpecifyBetween 0 and 0 *;
Special Storage Condition, SpecifyBetween 0 and 0 *;
Special Storage Condition, SpecifyBetween 0 and 0 *;
Special Storage Condition, SpecifyBetween 0 and 0 *;
Special Storage Condition, SpecifyBetween 0 and 0 *;
Special Storage Condition, SpecifyBetween 0 and 0 *;
Special Storage Condition, SpecifyBetween 0 and 0 *;
Special Storage Condition, SpecifyBetween 0 and 0 *;
Special Storage Condition, SpecifyBetween 0 and 0 *;

Device Identifiers

Device Issuing AgencyDevice ID
GS110884521178885 [Primary]
GS120884521178882 [Package]
Contains: 10884521178885
Package: CASE [3 Units]
Discontinued: 2019-10-21
Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FTLMesh, surgical, polymeric

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-12-06
Device Publish Date2015-10-06

On-Brand Devices [Parietex]

20884521176451Plug and Patch System,Monofilament Polyester and Polylactic Acid Semi-Resorbable Plug with Monof
20884521176444Plug and Patch System,Monofilament Polyester and Polylactic Acid Semi-Resorbable Plug with Monof
30884521176427Plug and Patch System,Monofilament Polyester and Polylactic Acid Semi-Resorbable Plug with Monof
20884521178882Lightweight Mesh,Monofilament Polyester

Trademark Results [Parietex]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PARIETEX
PARIETEX
75704884 2632191 Live/Registered
SOFRADIM PRODUCTION
1999-05-14
PARIETEX
PARIETEX
75171879 not registered Dead/Abandoned
COGENT
1996-09-25
PARIETEX
PARIETEX
75070367 not registered Dead/Abandoned
COGENT
1996-03-11

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