Catalog Number

01-1001-0600

Brand Name

PediFlex

Version/Model Number

01-1001-0600

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

-

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

K201838

Product Code

HTY

Product Code Name

PIN, FIXATION, SMOOTH

Public Device Record Key

e88c6c0e-9e66-444f-8304-775a47fd99a3

Public Version Date

March 04, 2021

Public Version Number

1

DI Record Publish Date

February 24, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-