FDA.reportPublic FDA data

Parietene

Primary DI
10884521213876
Brand
Parietene
Company
SOFRADIM PRODUCTION
Model
PPM1106X6
Device description
Macroporous Mesh, Monofilament Polypropylene
Published
2016-04-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FTLMesh, surgical, polymeric

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FTLMesh, Surgical, PolymericGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K142091000
K223218000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142091000PARIETENE MACROPOROUS MESHSofradim Production2014-10-17FTL
K223218000Parietene Macroporous MeshSofradim Production2022-12-02FTL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20884521213873PackageGS16In Commercial Distribution
10884521213876PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452121387320884521213873
1088452121387610884521213876

GMDN Terms#

Term, Definition table
TermDefinition
Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbableAn implantable material (e.g., flat sheet) made from a non-bioabsorbable synthetic polymer(s) [e.g., polyglycolic acid (PGA), polycarbonate (PC), polyglycolide or carbon fibres] intended for extra-gynaecological, non-dental tissue repair/reinforcement application(s) [e.g., pericardial reinforcement, plastic surgery, abdominal hernia repair]. Disposable devices associated with implantation may be supplied with the mesh.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length11Centimeter
Width6Centimeter

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
576342646
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20884521176420ParietexPNP6X32015-10-22
10884521190689Enduragen892212015-10-22
20884521176437ParietexPNP8X32015-10-22
10884521178465ParietexPCO2H32015-10-06
10884521179660ParietexPCO3728FX2015-10-12
10884521553521Parietene DSPPDS12X32017-12-15
10884521553538Parietene DSPPDS1510X32017-12-15
10884521553545Parietene DSPPDS15X32017-12-15
10884521553552Parietene DSPPDS2015X32017-12-15
10884521784086Parietene DSPPDS12X32020-01-26
10884521784093Parietene DSPPDS1510X32020-01-26
10884521784109Parietene DSPPDS15X32020-01-26
10884521784123Parietene DSPPDS2015X32020-01-26
10884523000023PermacolP0502052015-10-22
10884523000085PermacolP1003082015-10-16
10884521532298VersatexVTX5050M2016-04-15
10884521178472ParietexPCO2H42015-10-06
20884521176444ParietexPNP62015-10-06
20884521176451ParietexPNP82015-10-06
10884521190412SymbotexSYM1710E2015-10-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06970461300015TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300022TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300039TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300046TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300053TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300060TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300077TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300084TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300091TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300107TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300114TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300121TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300138TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300145TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300152TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300169TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300176TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300183TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300190TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300206TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300213TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300220TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300237TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300244TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300251TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300268TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300275TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300282TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300299TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300305TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22