Catalog Number

128518

Brand Name

NA

Version/Model Number

128518

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

-

Product Code

HTY

Product Code Name

PIN, FIXATION, SMOOTH

Public Device Record Key

b287aa49-b382-4ade-8c15-f29daf1655d1

Public Version Date

October 22, 2020

Public Version Number

3

DI Record Publish Date

August 29, 2015

Package DI Number

23596010084310

Quantity per Package

6

Contains DI Package

03596010084316

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BX