FDA.reportPublic FDA data

Transorb

Primary DI
10884521809703
Brand
Transorb
Company
SOFRADIM PRODUCTION
Model
TSB1510
Device description
Self-Gripping Resorbable Mesh Monofilament PLLA/TMC Textile and Grips
Published
2024-03-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OWTMesh, surgical, absorbable, abdominal hernia

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OWTMesh, Surgical, Absorbable, Abdominal HerniaGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K233661000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K233661000Transorb™ Self-Gripping Resorbable MeshSofradim Production2024-02-13OWT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884521809703PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088452180970310884521809703

GMDN Terms#

Term, Definition table
TermDefinition
Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbableAn implantable material (e.g., flat sheet) made from a 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]. It may also be intended as a short-term scaffold for tissue regeneration. Disposable devices associated with implantation may be supplied with the mesh.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height10Centimeter
Length15Centimeter

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
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
10884521190474SymbotexSYM2515E2015-10-06
10884521179004ParietenePP15152026-01-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07332999000222TIGR® Matrix Surgical MeshNovus Scientific ABOWT2025-08-29
07332999000239TIGR® Matrix Surgical MeshNovus Scientific ABOWT2025-08-29
07332999000246TIGR® Matrix Surgical MeshNovus Scientific ABOWT2025-08-29
07332999000468TIGR® Matrix Surgical MeshNovus Scientific ABOWT2025-08-29
07332999000475TIGR® Matrix Surgical MeshNovus Scientific ABOWT2025-08-29
00801741226519PhasixDavol Inc.OWT2025-02-24
00801741226533PhasixDavol Inc.OWT2025-02-24
00801741226571PhasixDavol Inc.OWT2025-02-24
10884521809710TransorbSOFRADIM PRODUCTIONOWT2024-03-08
10884521809727TransorbSOFRADIM PRODUCTIONOWT2024-03-08
10884521809734TransorbSOFRADIM PRODUCTIONOWT2024-03-08
10653405988946BioBraceConmed CorporationOWT2024-02-12
10653405988939BioBraceConmed CorporationOWT2024-02-12
10653405988953BioBraceConmed CorporationOWT2024-02-12
10653405988960BioBraceConmed CorporationOWT2024-02-12
00860006566708BioBrace 5mmBiorez, Inc.OWT2021-05-24
00801741161247PhasixDavol Inc.OWT2019-08-16
00801741161292PhasixDavol Inc.OWT2019-08-16
00801741161216PhasixDavol Inc.OWT2019-07-12
00801741161223PhasixDavol Inc.OWT2019-07-12
00801741161230PhasixDavol Inc.OWT2019-07-12
00801741161254PhasixDavol Inc.OWT2019-07-12
00801741161261PhasixDavol Inc.OWT2019-07-12
00801741161278PhasixDavol Inc.OWT2019-07-12
00801741161285PhasixDavol Inc.OWT2019-07-12
00801741161308PhasixDavol Inc.OWT2019-07-12
00801741163173PhasixDavol Inc.OWT2019-06-19
00801741163197PhasixDavol Inc.OWT2019-06-19
00801741163203PhasixDavol Inc.OWT2019-06-19
00801741163210PhasixDavol Inc.OWT2019-06-19