OviTex® 2S

Primary DI
09421904065154
Brand
OviTex® 2S
Company
AROA BIOSURGERY LIMITED
Model
F10248-0610P
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
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
K153632000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K153632000Endoform Reconstructive TemplateAroa Biosurgery Limited (Formerly Mesynthes Limited)2016-06-16FTL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09421904065154PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09421904065154094219040651549421904065154

GMDN Terms#

Term, Definition table
TermDefinition
Multi-purpose surgical mesh, biologic-polymer compositeA 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
Device Size Text, specify0
Length6Centimeter
Width10Centimeter

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
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
09421906017281Endoform™ Natural Restorative Bioscaffold5293112021-08-20
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
09421906017502Endoform™ Antimicrobial Restorative Bioscaffold6293112021-08-20
09421906661903OviTex® IHRF10244-1017I2024-03-21
09421906661927OviTex® IHRF10243-1017I2024-03-21
09421906661552OviTex® LPRF10244-1525L2023-06-15
09421906661569OviTex® LPRF10244-1520L2023-06-15

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Primary DI, Brand, Company table
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