Catalog Number

00-1000-635

Brand Name

PediFlex

Version/Model Number

00-1000-635

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

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

K082375

Product Code

HTY

Product Code Name

PIN, FIXATION, SMOOTH

Public Device Record Key

4d36253d-315b-482e-b35e-4683c4b515f8

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 08, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-