Catalog Number

00-1001-0035

Brand Name

PediFlex Advanced

Version/Model Number

00-1001-0035

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

K081097

Product Code

HTY

Product Code Name

PIN, FIXATION, SMOOTH

Public Device Record Key

5fdf8b29-e1f3-4659-87a8-f6f82d53407e

Public Version Date

July 06, 2018

Public Version Number

2

DI Record Publish Date

March 28, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-