FDA.reportPublic FDA data

OviTex® PRS

Primary DI
00856072005197
Brand
OviTex® PRS
Company
TELA BIO, INC.
Model
R20253-1122G
Device description
OviTex® PRS is for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery. The device is supplied sterile and is intended for one-time use.
Published
2020-09-14
Public version status
Update
Distribution status
Not 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

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K183398000Endoform RestellaAroa Biosurgery , Ltd.2019-04-11FTM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00856072005197PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00856072005197008560720051978560720051970856072005197

GMDN Terms#

Term, Definition table
TermDefinition
Multi-purpose surgical mesh, biologic-polymer compositeA sterile, flat or three-dimensional (3-D) implantable material comprised of both a bioabsorbable animal-derived biologic (e.g., porcine collagen) and a non-bioabsorbable synthetic polymer (e.g., polypropylene) intended for multiple defective tissue repair applications at different anatomical zones (e.g., breast, cardiac, abdominal) that includes an extra-abdominal application(s) [e.g., cardiac, plastic surgery, breast reconstruction]. It may also be used as a short-term scaffold for tissue regeneration. Disposable devices associated with implantation (e.g., introducer needles, trocars) may be included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length11.5Centimeter
Width22Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature0 Degrees Celsius25 Degrees Celsius

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
00856072005050OviTex® PRSR20143-0820PR20143-0820P2025-02-21
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

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