Catalog Number

PFX-426

Brand Name

PIP Fix

Version/Model Number

PFX-426

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)

Yes

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

K181192

Product Code

JEC

Product Code Name

Component, Traction, Invasive

Public Device Record Key

d0d4c2e4-26cd-46e5-907d-85f94bb31699

Public Version Date

March 11, 2019

Public Version Number

1

DI Record Publish Date

February 20, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-