Myriad Matrix Soft Tissue Bioscaffold - Myriad Matrix is intended for applications in - AROA BIOSURGERY LIMITED

Duns Number:594540572

Device Description: Myriad Matrix is intended for applications in plastic and reconstructive surgery or to cov Myriad Matrix is intended for applications in plastic and reconstructive surgery or to cover, protect and provide a moist wound environment. The device may be fixed, via sutures, staples or tacks to surround the tissue if desired.

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More Product Details

Catalog Number

-

Brand Name

Myriad Matrix Soft Tissue Bioscaffold

Version/Model Number

SR02LG2020US

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

K162461,K171231

Product Code Details

Product Code

FTL

Product Code Name

Mesh, Surgical, Polymeric

Device Record Status

Public Device Record Key

8a2485de-1f66-4c1b-a42f-42054d8cba4b

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

March 23, 2022

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