Catalog Number

77777

Brand Name

COPIOS® Pericardium Membrane

Version/Model Number

xz0123

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K073097

Product Code

NPL

Product Code Name

Barrier, animal source, intraoral

Public Device Record Key

1a610dd6-3d7e-4835-9f55-33fe0c163766

Public Version Date

April 07, 2021

Public Version Number

4

DI Record Publish Date

December 14, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-