Catalog Number

150-4100-118

Brand Name

TI WIN MF- 1.5 t-plate 3/8 holes, Titanium

Version/Model Number

150-4100-118

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

HRS

Product Code Name

Plate, fixation, bone

Public Device Record Key

9cd9ecec-9c99-4851-afda-67bca901bf55

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

August 01, 2016

Package DI Number

EMAH15041001181

Quantity per Package

1

Contains DI Package

EMAH15041001180

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-