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.
Catalog Number
-
Brand Name
Myriad Matrix Soft Tissue Bioscaffold
Version/Model Number
SR03LG1010US
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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
FTL
Product Code Name
Mesh, Surgical, Polymeric
Public Device Record Key
10c8a45a-7397-468d-bd33-5bab401cfa16
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
August 12, 2021
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| 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 |