FDA.reportPublic FDA data

SURGIMESH®WN

Primary DI
03700296902886
Brand
SURGIMESH®WN
Company
ASPIDE MEDICAL
Model
T1115-8TW
Catalog number
T1115-8TW
Device description
Non woven, non knitted reinforcement material made from polypropylene.
Published
2015-10-23
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
03700296903876PackageGS15In Commercial Distribution
03700296902886PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03700296903876037002969038763700296903876
03700296902886037002969028863700296902886

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., polycarbonate (PC), 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
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight
Special Storage Condition, Specify00Keep dry
Special Storage Condition, Specify00Store at room temperature

Regulatory Flags#

DUNS number
395941714
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03700296900554SURGIMESH®WNT613-8T613-82015-10-23
03700296900592SURGIMESH®WNT913ST913S2015-10-23
03700296900615SURGIMESH®WNT1014-8T1014-82015-10-23
03700296900639SURGIMESH®WNT1015T10152015-10-23
03700296900646SURGIMESH®WNT1115T11152015-10-23
03700296900653SURGIMESH®WNT1115-8T1115-82015-10-23
03700296900677SURGIMESH®WNT1415T14152015-10-23
03700296900684SURGIMESH®WNT1415-8T1415-82015-10-23
03700296900691SURGIMESH®WNT1515BT1515B2015-10-23
03700296900707SURGIMESH®WNT1518-8T1518-82015-10-23
03700296900721SURGIMESH®WNT221510T2215102015-10-23
03700296900738SURGIMESH®WNT302012T3020122015-10-23
03700296900745SURGIMESH®WNT3030T30302015-10-23
03700296900813SURGIMESH®WNT1518-8SRT1518-8SR2015-10-23
03700296900844SURGIMESH®EASYPLUG®TEALFIL-8TEALFIL-82015-10-23
03700296900882SURGIMESH®WNT1415-SRT1415-SR2016-08-01
03700296901094SURGIMESH®WNT1518T15182015-10-23
03700296901728SURGIMESH®WNT510T5102015-10-23
03700296902282SURGIMESH®WNT813-8TT813-8T2015-10-23
03700296902893SURGIMESH®WNT1015-8T1015-82015-10-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
09421905067751Ovitex® PRSAROA BIOSURGERY LIMITEDFTL2019-11-01