Catalog Number

OPA-2060

Brand Name

Inion FreedomPin™

Version/Model Number

1

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

K133932

Product Code

HTY

Product Code Name

PIN, FIXATION, SMOOTH

Public Device Record Key

39b625fb-fc62-4086-9e49-ef88d99a26f8

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

February 07, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-