FDA.reportPublic FDA data

DynaMesh

Primary DI
04250274701653
Brand
DynaMesh
Company
FEG Textiltechnik Forschungs- und Entwicklungsges. mbH
Model
PP standard 0630
Catalog number
PP020630F1
Device description
Hernia Mesh made of 100% Polypropylene
Published
2015-12-23
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

Product Codes#

Code, Name table
CodeName
FTLMesh, Surgical, Polymeric

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250274701653PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250274701653042502747016534250274701653

GMDN Terms#

Term, Definition table
TermDefinition
Abdominal hernia surgical mesh, synthetic polymer, non-bioabsorbableA sterile, flat or three-dimensional (3-D), woven/knitted or porous material made of one or more non-bioabsorbable synthetic polymers [e.g., polypropylene, polyethylene (PE)] intended to be permanently implanted for abdominal hernia (e.g., inguinal, ventral/incisional, umbilical, femoral) and fascial defect repair applications; it is not intended for extra-abdominal applications and not dedicated to diaphragmatic hernia repair. It is typically available with various material attributes and may be pre-configured or cut to a desired size/shape. Disposable devices associated with implantation (e.g., introducer needles, trocars) may be included.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
341661031
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04250274701516DynaMeshPP light 0605PP010605F12015-12-23
04250274701523DynaMeshPP light 0611PP010611F12015-12-23
04250274701530DynaMeshPP light 0630PP010630F12015-12-23
04250274701547DynaMeshPP light 0715PP010715F12015-12-23
04250274705620DynaMeshVENTRALPV230010F12017-05-08
04250274705644DynaMeshVENTRALPV231010F12017-05-08
04250274705682DynaMeshVENTRALPV233030F12017-05-08
04250274705729DynaMeshVENTRALPV231525F12017-05-08
04250274705781DynaMeshVENTRALPV232030F12017-05-08
04250274705811DynaMeshVENTRALPV233045F12017-05-08
04250274705859DynaMeshVENTRALPV232715F12017-05-08
04250274705873DynaMeshVENTRALPV234010F12017-05-08
04250274705903DynaMeshVENTRALPV231015F12017-05-08
04250274701554DynaMeshPP light 1015PP01015F12015-12-23
04250274701585DynaMeshPP light 1515PP011515F12015-12-23
04250274701608DynaMeshPP light 2030PP012030F12015-12-23
04250274701615DynaMeshPP light 3030PP013030F12015-12-23
04250274701622DynaMeshPP light 3045PP013045F12015-12-23
04250274701639DynaMeshPP standard 0605PP020605F12015-12-23
04250274701646DynaMeshPP standard 0611PP020611F12015-12-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05060267134561FORCECORD ImplantXIROS LTDFTL2026-07-06
09421907331874OviTex® CoreAROA BIOSURGERY LIMITEDFTL2025-11-26
09421907331928OviTex® CoreAROA BIOSURGERY LIMITEDFTL2025-11-26
09421907331966OviTex® 1SAROA BIOSURGERY LIMITEDFTL2025-11-26
09421907331997OviTex® 1SAROA BIOSURGERY LIMITEDFTL2025-11-26
09421908222072OviTex® Low ProfileAROA BIOSURGERY LIMITEDFTL2025-11-26
09421908222089OviTex® Low ProfileAROA BIOSURGERY LIMITEDFTL2025-11-26
09421908222119OviTex® Low ProfileAROA BIOSURGERY LIMITEDFTL2025-11-26
09421908222126OviTex® Low ProfileAROA BIOSURGERY LIMITEDFTL2025-11-26
09421908222140OviTex® InguinalAROA BIOSURGERY LIMITEDFTL2025-11-26
09421908222263OviTex® Low ProfileAROA BIOSURGERY LIMITEDFTL2025-11-26
10884521857179ParieteneSOFRADIM PRODUCTIONFTL2025-11-08
08903837165978Surgical MeshHEALTHIUM MEDTECH LIMITEDFTL2023-08-31
09421906661552OviTex® LPRAROA BIOSURGERY LIMITEDFTL2023-06-15
09421906661569OviTex® LPRAROA BIOSURGERY LIMITEDFTL2023-06-15
10705031085978ULTRAPROJohnson & Johnson International Inc.FTL2022-11-08
10705031085985ULTRAPROJohnson & Johnson International Inc.FTL2022-11-08
10607567510996TigerPaw Pro Left Atrial Appendage Closure DeviceDATASCOPE CORP.FTL2020-11-18
09421905067539OviTex® LPRAROA BIOSURGERY LIMITEDFTL2020-03-13
10884521784086Parietene DSSOFRADIM PRODUCTIONFTL2020-01-26
10884521784093Parietene DSSOFRADIM PRODUCTIONFTL2020-01-26
10884521784109Parietene DSSOFRADIM PRODUCTIONFTL2020-01-26
10884521784123Parietene DSSOFRADIM PRODUCTIONFTL2020-01-26
09421906017052Ovitex® PRSAROA BIOSURGERY LIMITEDFTL2019-11-29
09421905067157Ovitex® PRSAROA BIOSURGERY LIMITEDFTL2019-11-14
09421905067645Ovitex® PRSAROA BIOSURGERY LIMITEDFTL2019-11-01
09421905067690Ovitex® PRSAROA BIOSURGERY LIMITEDFTL2019-11-01
09421905067706Ovitex® PRSAROA BIOSURGERY LIMITEDFTL2019-11-01
09421905067713Ovitex® PRSAROA BIOSURGERY LIMITEDFTL2019-11-01
09421905067720Ovitex® PRSAROA BIOSURGERY LIMITEDFTL2019-11-01