Home GUDID 09421906661569 OviTex® LPR
Primary DI 09421906661569
Brand OviTex® LPR
Company AROA BIOSURGERY LIMITED
Model F10244-1520L
Device description The OviTex® Reinforced Tissue Matrix Device is a sterile reinforced matrix device comprised of non-dermal sourced layers of extracellular matrix (ECM) (ovine (sheep) derived ECM), paired with a minimal suture footprint. OviTex Reinforced Tissue Matrix Device provides an alternative device solution to permanent synthetic, resorbable/bioabsorbable synthetic, and biologic meshes. The device remodels and helps regenerate tissue while reinforcing the repair and providing structural support. Reinforced tissue matrices enhance performance while maintaining compatibility with the body. The OviTex Reinforced Tissue Matrix Device is used for hernia repair and abdominal wall reconstruction.
Published 2023-06-15
Public version status Update
Distribution status In Commercial Distribution
MRI safety MR Safe
Rx true
Sterile true
Single use true
Product Codes# Code, Name table Code Name FTL Mesh, Surgical, Polymeric FTM Mesh, Surgical
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FTL Mesh, Surgical, Polymeric General, Plastic Surgery 2 FTM Mesh, Surgical General, Plastic Surgery 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 09421906661569 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 09421906661569 09421906661569 9421906661569
GMDN Terms# Term, Definition table Term Definition Extra-gynaecological surgical mesh, biologic-polymer composite A partially-bioabsorbable, implantable material (e.g., flat sheet) made from both a bioabsorbable animal-derived biologic (e.g., porcine collagen) and a non-bioabsorbable synthetic polymer (e.g., polypropylene) 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 Type Value Unit Device Size Text, specify 0 Length 15 Centimeter Width 20 Centimeter
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Store at room temperature in a dry environment.
Regulatory Flags# DUNS number 594540572 Device count 1 Lot or batch true Manufacturing date on label true Expiration date on label true No natural rubber latex true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 09421908222515 Myriad Meshed Soft Tissue Bioscaffold MS01FV2030 2026-07-04 09421906017274 Endoform™ Natural Restorative Bioscaffold 529312 2021-08-20 09421906661910 OviTex® IHR F10243-1317I 2024-03-21 09421906017625 Myriad Matrix™ Soft Tissue Bioscaffold SR05LG0505US 2021-08-12 09421906017236 Endoform™ Natural Restorative Bioscaffold 529316 2021-08-20 09421906017243 Endoform™ Natural Restorative Bioscaffold 529315 2021-08-20 09421906017250 Endoform™ Natural Restorative Bioscaffold 529314 2021-08-20 09421906017267 Endoform™ Natural Restorative Bioscaffold 529313 2021-08-20 09421906017281 Endoform™ Natural Restorative Bioscaffold 529311 2021-08-20 09421906017304 Endoform™ Natural Restorative Bioscaffold 529302 2021-08-20 09421906017434 Endoform™ Antimicrobial Restorative Bioscaffold 629304 2021-08-20 09421906017465 Endoform™ Antimicrobial Restorative Bioscaffold 629315 2021-08-20 09421906017472 Endoform™ Antimicrobial Restorative Bioscaffold 629314 2021-08-20 09421906017489 Endoform™ Antimicrobial Restorative Bioscaffold 629313 2021-08-20 09421906017496 Endoform™ Antimicrobial Restorative Bioscaffold 629312 2021-08-20 09421906017502 Endoform™ Antimicrobial Restorative Bioscaffold 629311 2021-08-20 09421906661903 OviTex® IHR F10244-1017I 2024-03-21 09421906661927 OviTex® IHR F10243-1017I 2024-03-21 09421906661552 OviTex® LPR F10244-1525L 2023-06-15 09421906017670 Myriad Matrix™ Soft Tissue Bioscaffold SR02LG1010US 2022-04-01
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 06970461300015 Tisuthes Shanghai Suokang Medical Implants Co.,Ltd. FTL 2026-07-22 06970461300022 Tisuthes Shanghai Suokang Medical Implants Co.,Ltd. FTL 2026-07-22 06970461300039 Tisuthes Shanghai Suokang Medical Implants Co.,Ltd. FTL 2026-07-22 06970461300046 Tisuthes Shanghai Suokang Medical Implants Co.,Ltd. FTL 2026-07-22 06970461300053 Tisuthes Shanghai Suokang Medical Implants Co.,Ltd. FTL 2026-07-22 06970461300060 Tisuthes Shanghai Suokang Medical Implants Co.,Ltd. FTL 2026-07-22 06970461300077 Tisuthes Shanghai Suokang Medical Implants Co.,Ltd. FTL 2026-07-22 06970461300084 Tisuthes Shanghai Suokang Medical Implants Co.,Ltd. FTL 2026-07-22 06970461300091 Tisuthes Shanghai Suokang Medical Implants Co.,Ltd. FTL 2026-07-22 06970461300107 Tisuthes Shanghai Suokang Medical Implants Co.,Ltd. FTL 2026-07-22 06970461300114 Tisuthes Shanghai Suokang Medical Implants Co.,Ltd. FTL 2026-07-22 06970461300121 Tisuthes Shanghai Suokang Medical Implants Co.,Ltd. FTL 2026-07-22 06970461300138 Tisuthes Shanghai Suokang Medical Implants Co.,Ltd. FTL 2026-07-22 06970461300145 Tisuthes Shanghai Suokang Medical Implants Co.,Ltd. FTL 2026-07-22 06970461300152 Tisuthes Shanghai Suokang Medical Implants Co.,Ltd. FTL 2026-07-22 06970461300169 Tisuthes Shanghai Suokang Medical Implants Co.,Ltd. FTL 2026-07-22 06970461300176 Tisuthes Shanghai Suokang Medical Implants Co.,Ltd. FTL 2026-07-22 06970461300183 Tisuthes Shanghai Suokang Medical Implants Co.,Ltd. FTL 2026-07-22 06970461300190 Tisuthes Shanghai Suokang Medical Implants Co.,Ltd. FTL 2026-07-22 06970461300206 Tisuthes Shanghai Suokang Medical Implants Co.,Ltd. FTL 2026-07-22 06970461300213 Tisuthes Shanghai Suokang Medical Implants Co.,Ltd. FTL 2026-07-22 06970461300220 Tisuthes Shanghai Suokang Medical Implants Co.,Ltd. FTL 2026-07-22 06970461300237 Tisuthes Shanghai Suokang Medical Implants Co.,Ltd. FTL 2026-07-22 06970461300244 Tisuthes Shanghai Suokang Medical Implants Co.,Ltd. FTL 2026-07-22 06970461300251 Tisuthes Shanghai Suokang Medical Implants Co.,Ltd. FTL 2026-07-22 06970461300268 Tisuthes Shanghai Suokang Medical Implants Co.,Ltd. FTL 2026-07-22 06970461300275 Tisuthes Shanghai Suokang Medical Implants Co.,Ltd. FTL 2026-07-22 06970461300282 Tisuthes Shanghai Suokang Medical Implants Co.,Ltd. FTL 2026-07-22 06970461300299 Tisuthes Shanghai Suokang Medical Implants Co.,Ltd. FTL 2026-07-22 06970461300305 Tisuthes Shanghai Suokang Medical Implants Co.,Ltd. FTL 2026-07-22