Catalog Number

Z009-30

Brand Name

X-Repair

Version/Model Number

Z009-30

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K141394

Product Code

FTL

Product Code Name

Mesh, Surgical, Polymeric

Public Device Record Key

0c21fe61-8d15-4673-a0ee-74068625c340

Public Version Date

June 10, 2022

Public Version Number

5

DI Record Publish Date

January 05, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-