Parietene PPM1106

GUDID 10884521213739

Macroporous Mesh, Monofilament Polypropylene

SOFRADIM PRODUCTION

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
Primary Device ID10884521213739
NIH Device Record Key631e525c-984c-4028-823c-09a3545effbd
Commercial Distribution StatusIn Commercial Distribution
Brand NameParietene
Version Model NumberPPM1106
Catalog NumberPPM1106
Company DUNS576342646
Company NameSOFRADIM PRODUCTION
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

Device Dimensions

Width6 Centimeter
Length11 Centimeter
Width6 Centimeter
Length11 Centimeter
Width6 Centimeter
Length11 Centimeter
Width6 Centimeter
Length11 Centimeter
Width6 Centimeter
Length11 Centimeter
Width6 Centimeter
Length11 Centimeter
Width6 Centimeter
Length11 Centimeter
Width6 Centimeter
Length11 Centimeter
Width6 Centimeter
Length11 Centimeter
Width6 Centimeter
Length11 Centimeter
Width6 Centimeter
Length11 Centimeter
Width6 Centimeter
Length11 Centimeter
Width6 Centimeter
Length11 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 *;

Device Identifiers

Device Issuing AgencyDevice ID
GS110884521213739 [Primary]
GS110884521213739 [Primary]
GS110884521213739 [Primary]
GS110884521213739 [Primary]
GS110884521213739 [Primary]
GS110884521213739 [Primary]
GS110884521213739 [Primary]
GS110884521213739 [Primary]
GS110884521213739 [Primary]
GS110884521213739 [Primary]
GS110884521213739 [Primary]
GS110884521213739 [Primary]
GS110884521213739 [Primary]

FDA Product Code

FTLMesh, surgical, polymeric
FTLMesh, surgical, polymeric
FTLMesh, surgical, polymeric
FTLMesh, surgical, polymeric
FTLMesh, surgical, polymeric
FTLMesh, surgical, polymeric
FTLMesh, surgical, polymeric
FTLMesh, surgical, polymeric
FTLMesh, surgical, polymeric
FTLMesh, surgical, polymeric
FTLMesh, surgical, polymeric
FTLMesh, surgical, polymeric
FTLMesh, surgical, polymeric

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2020-09-15
Device Publish Date2016-06-01

Devices Manufactured by SOFRADIM PRODUCTION

10884521213739 - Parietene2020-09-15Macroporous Mesh, Monofilament Polypropylene
10884521213739 - Parietene2020-09-15 Macroporous Mesh, Monofilament Polypropylene
10884521178458 - Parietex2020-08-17 Composite Mesh,Polyester with Absorbable Collagen Film
10884521179974 - Parietex2020-08-17 Hydrophilic 3-Dimensional Mesh,Polyester
10884521180031 - Parietex2020-08-17 Hydrophilic 2-Dimensional Mesh,Polyester
10884521180147 - Parietex2020-08-17 Hydrophilic 3-Dimensional Mesh,Polyester
10884521180154 - Parietex2020-08-17 Hydrophilic Anatomical Mesh,Left Side, Polyester
10884521180260 - Parietex2020-08-17 Hydrophilic 2-Dimensional Mesh,Polyester
10884521180345 - Parietex2020-08-17 Hydrophilic 3-Dimensional Mesh,Polyester

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