Catalog Number

0846832000319

Brand Name

Insite™ FT Ti

Version/Model Number

0846832000319

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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"

Yes

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

MBI

Product Code Name

FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Public Device Record Key

525aedde-8fbb-4f82-9187-e1ddb3679681

Public Version Date

May 11, 2022

Public Version Number

5

DI Record Publish Date

October 16, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-