Ovitex® PRS - Ovitex® PRS is for implantation to reinforce soft - AROA BIOSURGERY LIMITED

Duns Number:594540572

Device Description: Ovitex® PRS is for implantation to reinforce soft tissue where weakness exists in patients 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.

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More Product Details

Catalog Number

-

Brand Name

Ovitex® PRS

Version/Model Number

R20353-1622G

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 28, 2020

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Safe

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

-

Product Code Details

Product Code

FTL

Product Code Name

Mesh, Surgical, Polymeric

Device Record Status

Public Device Record Key

5eb70a64-87dd-440d-b53b-c78bf401ffd6

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

November 01, 2019

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