FDA.reportPublic FDA data

OviTex® 1S

Primary DI
09421904065314
Brand
OviTex® 1S
Company
AROA BIOSURGERY LIMITED
Model
F10256-1020G
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
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FTMMesh, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FTMMesh, SurgicalGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K153633000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K153633000Endoform Reconstructive TemplateAroa Biosurgery Limited (Formerly Mesynthes Limited)2016-03-15FTM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09421904065314PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09421904065314094219040653149421904065314

GMDN Terms#

Term, Definition table
TermDefinition
Multi-purpose surgical mesh, collagen, bioabsorbableA sterile, bioabsorbable, flat or three-dimensional (3-D) implantable material made from animal-derived collagen intended for multiple tissue defect repair/hernia reduction (e.g., inguinal, ventral/incisional, umbilical, femoral) applications including an extra-abdominal application(s) [e.g., 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
Device Size Text, specify0
Length10Centimeter
Width20Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store at room temperature in a dry environment.
Storage Environment Temperature25 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8448352246customerservice@telabio.com

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 DIBrandModelCatalogPublished
09421904065727OviTex® 1SF10246-2530P2018-12-13
09421904065734OviTex® 1SF10246-2540P2018-12-13
09421904065741OviTex® 2SF10248-2530P2018-12-13
09421904065758OviTex® 2SF10248-2540P2018-12-13
09421904065246OviTex® CoreF10254-1020G2016-09-24
09421906017281Endoform™ Natural Restorative Bioscaffold5293112021-08-20
09421908222515Myriad Meshed Soft Tissue BioscaffoldMS01FV20302026-07-04
09421906017274Endoform™ Natural Restorative Bioscaffold5293122021-08-20
09421906661910OviTex® IHRF10243-1317I2024-03-21
09421906017625Myriad Matrix™ Soft Tissue BioscaffoldSR05LG0505US2021-08-12
09421906017236Endoform™ Natural Restorative Bioscaffold5293162021-08-20
09421906017243Endoform™ Natural Restorative Bioscaffold5293152021-08-20
09421906017250Endoform™ Natural Restorative Bioscaffold5293142021-08-20
09421906017267Endoform™ Natural Restorative Bioscaffold5293132021-08-20
09421906017304Endoform™ Natural Restorative Bioscaffold5293022021-08-20
09421906017434Endoform™ Antimicrobial Restorative Bioscaffold6293042021-08-20
09421906017465Endoform™ Antimicrobial Restorative Bioscaffold6293152021-08-20
09421906017472Endoform™ Antimicrobial Restorative Bioscaffold6293142021-08-20
09421906017489Endoform™ Antimicrobial Restorative Bioscaffold6293132021-08-20
09421906017496Endoform™ Antimicrobial Restorative Bioscaffold6293122021-08-20

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
09421907331881OviTex® CoreAROA BIOSURGERY LIMITEDFTM2025-11-26
09421907331935OviTex® 1SAROA BIOSURGERY LIMITEDFTM2025-11-26
09421907331942OviTex® 1SAROA BIOSURGERY LIMITEDFTM2025-11-26
09421907331959OviTex® 1SAROA BIOSURGERY LIMITEDFTM2025-11-26
09421907331973OviTex® 1SAROA BIOSURGERY LIMITEDFTM2025-11-26
09421908222065OviTex® 2SAROA BIOSURGERY LIMITEDFTM2025-11-26
09421908222096OviTex® Low ProfileAROA BIOSURGERY LIMITEDFTM2025-11-26
09421908222102OviTex® Low ProfileAROA BIOSURGERY LIMITEDFTM2025-11-26
09421908222157OviTex® InguinalAROA BIOSURGERY LIMITEDFTM2025-11-26
00859389005331EluPro Antibiotic-Eluting BioEnvelopeElutia Med LLCFTM2024-09-06
00859389005348EluPro Antibiotic-Eluting BioEnvelopeElutia Med LLCFTM2024-09-06
B454VSC10VersaWrapAlafair Biosciences, Inc.FTM2024-06-10
09421906661903OviTex® IHRAROA BIOSURGERY LIMITEDFTM2024-03-21
09421906661910OviTex® IHRAROA BIOSURGERY LIMITEDFTM2024-03-21
09421906661927OviTex® IHRAROA BIOSURGERY LIMITEDFTM2024-03-21
09421906661880Myriad Ultra™ Reinforced BioScaffold – Permanent (PP)AROA BIOSURGERY LIMITEDFTM2022-11-28
09421906661897Myriad Ultra™ Reinforced BioScaffold – Permanent (PP)AROA BIOSURGERY LIMITEDFTM2022-11-28
09421906017670Myriad Matrix™ Soft Tissue BioscaffoldAROA BIOSURGERY LIMITEDFTM2022-04-01
09421906017663Myriad Matrix™ Soft Tissue BioscaffoldAROA BIOSURGERY LIMITEDFTM2022-03-23