Catalog Number

-

Brand Name

NA

Version/Model Number

430125SINGLE

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"

-

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

K131459

Product Code

HTY

Product Code Name

PIN, FIXATION, SMOOTH

Public Device Record Key

acee6ec6-bddc-4a75-a8f9-ce486e77f9ef

Public Version Date

November 16, 2018

Public Version Number

4

DI Record Publish Date

October 13, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-