COVAMESH - Polyester mesh coated with collagen membrane - BIOM' UP

Duns Number:277619636

Device Description: Polyester mesh coated with collagen membrane

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More Product Details

Catalog Number

CVM2520US

Brand Name

COVAMESH

Version/Model Number

MSH 11 2520 V

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 26, 2016

Issuing Agency

In GS1

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"

-

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

8811d4e3-4a23-43de-9f8c-0c96790506ca

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

February 26, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BIOM' UP" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 22