Catalog Number

1346001000

Brand Name

NA

Version/Model Number

1346001000

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

38ac78b8-7211-4b32-8cc0-9fcc017ee8fe

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 23, 2015

Package DI Number

34546540029479

Quantity per Package

6

Contains DI Package

04546540029478

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

pack