OviTex Reinforced Bioscaffold With Permanent Polymer (OviTex) - OviTex™ 2S Reinforced Tissue Matrix with - AROA BIOSURGERY LIMITED

Duns Number:594540572

Device Description: OviTex™ 2S Reinforced Tissue Matrix with Permanent Polymer (OviTex 2S) is a sterile biosca

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More Product Details

Catalog Number

F10248-0610P

Brand Name

OviTex Reinforced Bioscaffold With Permanent Polymer (OviTex)

Version/Model Number

F10248-0610P

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

df04d68c-4872-47e7-bf5f-cedf3c89c75f

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