Catalog Number

DTN1610EX3

Brand Name

Duatene

Version/Model Number

DTN1610EX3

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

K172395,K172395

Product Code

FTL

Product Code Name

Mesh, surgical, polymeric

Public Device Record Key

f7095925-c9f5-40d2-b00e-b139b51b47e0

Public Version Date

June 10, 2022

Public Version Number

5

DI Record Publish Date

March 12, 2018

Package DI Number

20884521726618

Quantity per Package

3

Contains DI Package

10884521726611

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE