FDA.reportPublic FDA data

SurgiMesh

Primary DI
00850011929209
Brand
SurgiMesh
Company
BG MEDICAL, LLC
Model
T613-8S
Published
2020-01-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K061445000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K061445000SURGIMESH WNAspide Medical2007-02-01FTL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850011929206PackageGS15In Commercial Distribution
00850011929209PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085001192920610850011929206
00850011929209008500119292098500119292090850011929209

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
825244135
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850011929278SurgiMeshT4040T40402023-08-29
00850011929292SurgiMeshT5050T50502023-08-29
00850011929001SurgiMeshTintra C-102020-01-30
00850011929018SurgiMeshTintra C-122020-01-30
00850011929025SurgiMeshTintra C-152020-01-30
00850011929032SurgiMeshTintra R-14152020-01-30
00850011929049SurgiMeshTintra E-15222020-01-30
00850011929056SurgiMeshTintra E-22262020-01-30
00850011929063SurgiMeshTintra E-30302020-01-30
00850011929070SurgiMeshTintra O-26362020-01-30
00850011929094SurgiMeshTintra CK-72020-01-30
00850011929100SurgiMeshTintra CK-10 2020-01-30
00850011929117SurgiMeshTintra OK-10152020-01-30
00850011929124SurgiMeshTintra OK-15222020-01-30
00850011929131SurgiMeshT5102020-01-30
00850011929148SurgiMeshT10152020-01-30
00850011929155SurgiMeshT14152020-01-30
00850011929179SurgiMeshT2215102020-01-30
00850011929186SurgiMeshT30302020-01-30
00850011929193SurgiMeshTEALFIL-82020-01-30

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