Catalog Number

45958S

Brand Name

NA

Version/Model Number

459.58S

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 22, 2020

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

K962047,K970733,K970097

Product Code

HTY

Product Code Name

PIN, FIXATION, SMOOTH

Public Device Record Key

fd769894-29a3-42d0-b2aa-e4eafd639080

Public Version Date

June 22, 2020

Public Version Number

5

DI Record Publish Date

September 14, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-