Catalog Number

-

Brand Name

TITAN™ DOUBLE WIRE

Version/Model Number

132.641.22

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

PTX

Product Code Name

Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile, Exempt

Public Device Record Key

d42437c7-ac99-4ecb-913a-26236285500c

Public Version Date

December 22, 2021

Public Version Number

3

DI Record Publish Date

October 10, 2021

Package DI Number

00853190008154

Quantity per Package

12

Contains DI Package

00853190008987

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton