Catalog Number

-

Brand Name

Meso Wound Matrix

Version/Model Number

30052-14

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K112888

Product Code

KGN

Product Code Name

Dressing, Wound, Collagen

Public Device Record Key

e56c0967-9a04-4482-a25b-1d338eab1ec0

Public Version Date

May 06, 2020

Public Version Number

5

DI Record Publish Date

September 15, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-