OviTex Reinforced Bioscaffold With Permanent Polymer (OviTex) - OviTex™ Core Reinforced Tissue Matrix with - AROA BIOSURGERY LIMITED

Duns Number:594540572

Device Description: OviTex™ Core Reinforced Tissue Matrix with Permanent Polymer (OviTex) is a sterile bioscaf OviTex™ Core Reinforced Tissue Matrix with Permanent Polymer (OviTex) is a sterile bioscaffold composed of ovine (sheep) derived extracellular matrix (ECM) and monofilament polypropylene colored with ([phathalocyaninato(2-)] copper). OviTex will incorporate into the recipient tissue with associated cellular and microvascular ingrowth.OviTex is provided in various shapes and sizes to suit surgeon preference and the complexity of the soft tissue repair. The device may be trimmed to a desired shape to further accommodate an individual patient’s requirements.

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More Product Details

Catalog Number

F10244-2020P

Brand Name

OviTex Reinforced Bioscaffold With Permanent Polymer (OviTex)

Version/Model Number

F10244-2020P

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K153632

Product Code Details

Product Code

FTL

Product Code Name

Mesh, Surgical, Polymeric

Device Record Status

Public Device Record Key

58c5e93e-6734-43de-8b33-b406edc37504

Public Version Date

June 10, 2022

Public Version Number

8

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"AROA BIOSURGERY LIMITED" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 135
U Unclassified 33