Catalog Number

RFS-PA20

Brand Name

RFS Disposable Pin Applicator

Version/Model Number

RFS-PA20

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 31, 2017

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

K080879

Product Code

HTY

Product Code Name

Pin, Fixation, Smooth

Public Device Record Key

f52df8ca-164b-4a9f-825e-3e5b2d6dc895

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 22, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-