Home GUDID 00856072005012 OviTex® PRS
Primary DI 00856072005012
Brand OviTex® PRS
Company TELA BIO, INC.
Model R20152-2020G
Device description The OviTex® PRS 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. The OviTex PRS Reinforced Tissue Matrix Device provides an alternative device solution to permanent synthetic, resorbable/bioabsorbable synthetic, and biologic meshes. The device is permeable to facilitate fluid management, provides controlled stretch, and will incorporate into recipient tissue with associated cellular and microvascular ingrowth. Reinforced tissue matrices remodel into host tissue while maintaining compatibility with the body. The OviTex PRS Reinforced Tissue Matrix Device is for use in plastic and reconstructive surgery.
Published 2020-05-15
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 00856072005012 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00856072005012 00856072005012 856072005012 0856072005012
Device Sizes# Type, Value, Unit table Type Value Unit Length 20 Centimeter Width 20.5 Centimeter
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Temperature 0 Degrees Celsius 25 Degrees Celsius
Regulatory Flags# DUNS number 078721472 Device count 1 Lot or batch true Expiration date on label true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 10381780545774 TissueMend® INTEGRA LIFESCIENCES FTM 2026-11-02 10381780545781 TissueMend® INTEGRA LIFESCIENCES FTM 2026-11-02 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