Catalog Number

-

Brand Name

Versatex

Version/Model Number

VTX1510X3

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

-

Product Code

FTL

Product Code Name

Mesh, Surgical, Polymeric

Public Device Record Key

62eb03a3-7877-4f76-83db-98857d31d6d4

Public Version Date

September 20, 2022

Public Version Number

11

DI Record Publish Date

April 15, 2016

Package DI Number

20884521532622

Quantity per Package

3

Contains DI Package

10884521532625

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE