Catalog Number

8-11070

Brand Name

TREU

Version/Model Number

8-11070

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"

-

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

K083912

Product Code

JDW

Product Code Name

Pin, Fixation, Threaded

Public Device Record Key

3d76b3e7-909c-4ca9-bbb8-b95af3740869

Public Version Date

July 16, 2018

Public Version Number

1

DI Record Publish Date

June 13, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-