FDA.reportPublic FDA data

OviTex® PRS

Primary DI
00856072005050
Brand
OviTex® PRS
Company
TELA BIO, INC.
Model
R20143-0820P
Catalog number
R20143-0820P
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
2025-02-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FTLMesh, Surgical, Polymeric
FTMMesh, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FTLMesh, Surgical, PolymericGeneral, Plastic Surgery2
FTMMesh, SurgicalGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K183398000
K241126000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K183398000Endoform RestellaAroa Biosurgery , Ltd.2019-04-11FTM
K241126000OviTex PRSTELA Bio, Inc.2024-05-22FTM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00856072005050PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00856072005050008560720050508560720050500856072005050

GMDN Terms#

Term, Definition table
TermDefinition
Extra-gynaecological surgical mesh, biologic-polymer compositeA 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
TypeValueUnit
Length8.5Centimeter
Width20Centimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-844-835-2246customerservice@telabio.com

Regulatory Flags#

DUNS number
078721472
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810055071203OviTex® F10381-0305TF10381-0305T2026-03-27
00810055071173OviTex® F10379-1317TF10379-1317T2025-12-05
00810055071166OviTex® F10378-0715TF10378-0715T2025-08-06
00810055071159OviTex® F10377-1515T2025-07-08
00810055070183OviTex® PRSP20163-1620GP20163-1620G2023-07-12
00810055070275OviTex® PRSP20163-2020GP20163-2020G2023-07-12
00810055070442OviTex® PRSP20363-2025GP20363-2025G2023-07-12
00810055070619OviTex® PRSP20263-0815GP20263-0815G2023-07-12
00810055070770OviTex® PRSP20263-1020GP20263-1020G2023-07-12
00810055070855OviTex® PRSP20263-1122GP20263-1122G2023-07-12
00810055071067OviTex® PRSP20463-2525GP20463-2525G2025-02-21
00810055071074OviTex® PRSP20363-2530GP20363-2530G2025-02-21
00856072005142OviTex® PRSR20243-1122P2022-01-04
00856072005043OviTex® PRSR20143-0416P2020-09-14
00856072005074OviTex® PRSR20143-2020P2020-09-14
00856072005135OviTex® PRSR20243-1018P2020-09-14
00856072005005OviTex® PRSR20152-1620G2020-05-15
00856072005012OviTex® PRSR20152-2020G2020-05-15
00856072005029OviTex® PRSR20252-0815G2020-05-15
00856072005036OviTex® PRSR20252-1122G2020-05-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00802526629907CanGaroo®Boston Scientific CorporationFTM2026-05-27
00802526629914CanGaroo®Boston Scientific CorporationFTM2026-05-27
00802526629921CanGaroo®Boston Scientific CorporationFTM2026-05-27
00802526629938CanGaroo®Boston Scientific CorporationFTM2026-05-27
00802526629945CanGaroo®Boston Scientific CorporationFTM2026-05-27
00802526630002EluPro™Boston Scientific CorporationFTM2026-05-27
00802526630019EluPro™Boston Scientific CorporationFTM2026-05-27
09421908222393Myriad Matrix™ Restore Restorative BioscaffoldAROA BIOSURGERY LIMITEDFTM2026-01-30
09421908222416Myriad Matrix™ Restore Restorative BioscaffoldAROA BIOSURGERY LIMITEDFTM2026-01-30
09421908222430Myriad Matrix™ Restore Restorative BioscaffoldAROA BIOSURGERY LIMITEDFTM2026-01-30
09421908222454Myriad Matrix™ Restore Restorative BioscaffoldAROA BIOSURGERY LIMITEDFTM2026-01-30
09421907331874OviTex® CoreAROA BIOSURGERY LIMITEDFTL2025-11-26
09421907331881OviTex® CoreAROA BIOSURGERY LIMITEDFTM2025-11-26
09421907331928OviTex® CoreAROA BIOSURGERY LIMITEDFTL2025-11-26
09421907331935OviTex® 1SAROA BIOSURGERY LIMITEDFTM2025-11-26
09421907331942OviTex® 1SAROA BIOSURGERY LIMITEDFTM2025-11-26
09421907331959OviTex® 1SAROA BIOSURGERY LIMITEDFTM2025-11-26
09421907331966OviTex® 1SAROA BIOSURGERY LIMITEDFTL2025-11-26
09421907331973OviTex® 1SAROA BIOSURGERY LIMITEDFTM2025-11-26
09421907331997OviTex® 1SAROA BIOSURGERY LIMITEDFTL2025-11-26
09421908222065OviTex® 2SAROA BIOSURGERY LIMITEDFTM2025-11-26
09421908222072OviTex® Low ProfileAROA BIOSURGERY LIMITEDFTL2025-11-26
09421908222089OviTex® Low ProfileAROA BIOSURGERY LIMITEDFTL2025-11-26
09421908222096OviTex® Low ProfileAROA BIOSURGERY LIMITEDFTM2025-11-26
09421908222102OviTex® Low ProfileAROA BIOSURGERY LIMITEDFTM2025-11-26
09421908222119OviTex® Low ProfileAROA BIOSURGERY LIMITEDFTL2025-11-26
09421908222126OviTex® Low ProfileAROA BIOSURGERY LIMITEDFTL2025-11-26
09421908222140OviTex® InguinalAROA BIOSURGERY LIMITEDFTL2025-11-26
09421908222157OviTex® InguinalAROA BIOSURGERY LIMITEDFTM2025-11-26
09421908222263OviTex® Low ProfileAROA BIOSURGERY LIMITEDFTL2025-11-26