Parietex TCM1515X3

GUDID 20884521178882

Lightweight Mesh,Monofilament Polyester

Covidien LP

Abdominal hernia surgical mesh, synthetic polymer, non-bioabsorbable Abdominal hernia surgical mesh, synthetic polymer, non-bioabsorbable, non-antimicrobial Abdominal hernia surgical mesh, synthetic polymer, non-bioabsorbable, non-antimicrobial Abdominal hernia surgical mesh, synthetic polymer, non-bioabsorbable, non-antimicrobial Abdominal hernia surgical mesh, synthetic polymer, non-bioabsorbable, non-antimicrobial Abdominal hernia surgical mesh, synthetic polymer, non-bioabsorbable, non-antimicrobial Abdominal hernia surgical mesh, synthetic polymer, non-bioabsorbable, non-antimicrobial Abdominal hernia surgical mesh, synthetic polymer, non-bioabsorbable, non-antimicrobial Abdominal hernia surgical mesh, synthetic polymer, non-bioabsorbable, non-antimicrobial Abdominal hernia surgical mesh, synthetic polymer, non-bioabsorbable, non-antimicrobial Abdominal hernia surgical mesh, synthetic polymer, non-bioabsorbable, non-antimicrobial Abdominal hernia surgical mesh, synthetic polymer, non-bioabsorbable, non-antimicrobial Abdominal hernia surgical mesh, synthetic polymer, non-bioabsorbable, non-antimicrobial Abdominal hernia surgical mesh, synthetic polymer, non-bioabsorbable, non-antimicrobial Abdominal hernia surgical mesh, synthetic polymer, non-bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable

Primary Device ID	20884521178882
NIH Device Record Key	620bf894-148d-4aba-a722-3626d6d9fab4
Commercial Distribution Discontinuation	2019-10-21
Commercial Distribution Status	Not in Commercial Distribution
Brand Name	Parietex
Version Model Number	TCM1515X3
Catalog Number	TCM1515X3
Company DUNS	058614483
Company Name	Covidien LP
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

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

Device Dimensions

Width	15 Centimeter
Length	15 Centimeter
Width	15 Centimeter
Length	15 Centimeter
Width	15 Centimeter
Length	15 Centimeter
Width	15 Centimeter
Length	15 Centimeter
Width	15 Centimeter
Length	15 Centimeter
Width	15 Centimeter
Length	15 Centimeter
Width	15 Centimeter
Length	15 Centimeter
Width	15 Centimeter
Length	15 Centimeter
Width	15 Centimeter
Length	15 Centimeter
Width	15 Centimeter
Length	15 Centimeter
Width	15 Centimeter
Length	15 Centimeter
Width	15 Centimeter
Length	15 Centimeter
Width	15 Centimeter
Length	15 Centimeter
Width	15 Centimeter
Length	15 Centimeter
Width	15 Centimeter
Length	15 Centimeter
Width	15 Centimeter
Length	15 Centimeter
Width	15 Centimeter
Length	15 Centimeter
Width	15 Centimeter
Length	15 Centimeter
Width	15 Centimeter
Length	15 Centimeter
Width	15 Centimeter
Length	15 Centimeter
Width	15 Centimeter
Length	15 Centimeter
Width	15 Centimeter
Length	15 Centimeter
Width	15 Centimeter
Length	15 Centimeter
Width	15 Centimeter
Length	15 Centimeter
Width	15 Centimeter
Length	15 Centimeter
Width	15 Centimeter
Length	15 Centimeter
Width	15 Centimeter
Length	15 Centimeter
Width	15 Centimeter
Length	15 Centimeter
Width	15 Centimeter
Length	15 Centimeter
Width	15 Centimeter
Length	15 Centimeter
Width	15 Centimeter
Length	15 Centimeter
Width	15 Centimeter
Length	15 Centimeter
Width	15 Centimeter
Length	15 Centimeter
Width	15 Centimeter
Length	15 Centimeter
Width	15 Centimeter
Length	15 Centimeter
Width	15 Centimeter
Length	15 Centimeter
Width	15 Centimeter
Length	15 Centimeter
Width	15 Centimeter

Operating and Storage Conditions

Special Storage Condition, Specify	Between 0 and 0 *;
Special Storage Condition, Specify	Between 0 and 0 *;
Special Storage Condition, Specify	Between 0 and 0 *;
Special Storage Condition, Specify	Between 0 and 0 *;
Special Storage Condition, Specify	Between 0 and 0 *;
Special Storage Condition, Specify	Between 0 and 0 *;
Special Storage Condition, Specify	Between 0 and 0 *;
Special Storage Condition, Specify	Between 0 and 0 *;
Special Storage Condition, Specify	Between 0 and 0 *;
Special Storage Condition, Specify	Between 0 and 0 *;
Special Storage Condition, Specify	Between 0 and 0 *;
Special Storage Condition, Specify	Between 0 and 0 *;
Special Storage Condition, Specify	Between 0 and 0 *;
Special Storage Condition, Specify	Between 0 and 0 *;
Special Storage Condition, Specify	Between 0 and 0 *;

Device Identifiers

Device Issuing Agency	Device ID
GS1	10884521178885 [Primary]
GS1	20884521178882 [Package] Contains: 10884521178885 Package: CASE [3 Units] Discontinued: 2019-10-21 Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K090858

FDA Product Code

FTL	Mesh, surgical, polymeric

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	5
Public Version Date	2019-12-06
Device Publish Date	2015-10-06

On-Brand Devices [Parietex]

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

Trademark Results [Parietex]

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