Catalog Number

DXT1612AR

Brand Name

Dextile

Version/Model Number

DXT1612AR

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

K192443

Product Code

FTL

Product Code Name

Mesh, surgical, polymeric

Public Device Record Key

0561443f-9e88-4fb4-8dd7-e4bff8674c71

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

January 10, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-