Catalog Number

CXL1097P

Brand Name

ARTIA Reconstructive Tissue Matrix

Version/Model Number

CXL1097P

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

K162752

Product Code

FTM

Product Code Name

Mesh, Surgical

Public Device Record Key

971a73b8-241e-47e3-ba81-3bed7e8be2e0

Public Version Date

June 10, 2022

Public Version Number

5

DI Record Publish Date

December 18, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-