Catalog Number

-

Brand Name

C-QUR MOSAIC

Version/Model Number

31142

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 31, 2019

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

K121070,K151386

Product Code

FTL

Product Code Name

Mesh, surgical, polymeric

Public Device Record Key

df2aef2b-319e-4ef5-b3e3-70850dde35c2

Public Version Date

June 10, 2022

Public Version Number

7

DI Record Publish Date

September 24, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-