FDA.reportPublic FDA data

Silicone Sheeting Open Border

Primary DI
00684995320031
Brand
Silicone Sheeting Open Border
Company
BENTEC MEDICAL OPCO, LLC
Model
PR72034-03
Published
2017-01-11
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
K840172000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K840172000VENTRAL WALL DEFECT REDUCT SILOAmerican Heyer Schulte1984-06-27FTL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00684995320031PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00684995320031006849953200316849953200310684995320031

GMDN Terms#

Term, Definition table
TermDefinition
Silicone-sheet tissue reconstructive material, sterileA sterile, flat stretch of silicone elastomer typically modified to suit the patient anatomy and intended to be implanted for tissue reconstruction during a surgical procedure. The device may be reinforced (e.g., with polyester textile), and may be cut into different sizes and shapes for various reconstructive otorhinolaryngology/head and neck surgery applications (e.g., repair of nasal septums, perforated eardrums).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080524654
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
00684995300316Silicone Sheeting, Non-ReinforcedPR72034-60N2023-10-20
00684995310261Silicone Sheeting, ReinforcedPR72034-015SPR2023-10-20
10684995300009Silicone Sheeting Non-ReinforcedPR72034-66N2017-01-11
10684995300016Silicone Sheeting Non-ReinforcedPR72034-62N2017-01-11
10684995300023Silicone Sheeting Non-ReinforcedPR72034-64N2017-01-11
10684995300030Silicone Sheeting Non-ReinforcedPR72034-51N2017-01-11
10684995300047Silicone Sheeting Non-ReinforcedPR72034-52N2017-01-11
10684995300054Silicone Sheeting Non-ReinforcedPR72034-53N2017-01-11
10684995300061Silicone Sheeting Non-ReinforcedPR72034-54N2017-01-11
10684995300078Silicone Sheeting Non-ReinforcedPR72034-20N2017-01-11
10684995300085Silicone Sheeting Non-ReinforcedPR72034-21N2017-01-11
10684995300092Silicone Sheeting Non-ReinforcedPR72034-22N2017-01-11
10684995300108Silicone Sheeting Non-ReinforcedPR72034-23N2017-01-11
10684995300115Silicone Sheeting Non-ReinforcedPR72034-24N2017-01-11
10684995310008Silicone Sheeting ReinforcedPR72034-51R2017-01-11
10684995310015Silicone Sheeting ReinforcedPR72034-52R2017-01-11
10684995310022Silicone Sheeting ReinforcedPR72034-53R2017-01-11
10684995310039Silicone Sheeting ReinforcedPR72034-54R2017-01-11
10684995310046Silicone Sheeting ReinforcedPR72034-55R2017-01-11
10684995310169Silicone Sheeting ReinforcedPR72034-60R2017-01-11

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