Meso BioMatrix™ Acellular Peritoneum Matrix - DSM BIOMEDICAL, INC.

Duns Number:131107757

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More Product Details

Catalog Number

-

Brand Name

Meso BioMatrix™ Acellular Peritoneum Matrix

Version/Model Number

30051-05

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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"

Yes

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

FTM

Product Code Name

Mesh, Surgical

Device Record Status

Public Device Record Key

5ba8719f-7fa9-48a6-b3f4-583d56fdd6a1

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

September 15, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DSM BIOMEDICAL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 9
2 A medical device with a moderate to high risk that requires special controls. 132
U Unclassified 5