Catalog Number

01-1007-0001

Brand Name

OrthoPediatrics PediFoot Deformity Correction System

Version/Model Number

01-1007-0001

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

-

Product Code

LHX

Product Code Name

Trousers, anti-shock

Public Device Record Key

fcd8dbfe-f3a9-4171-b91b-b66e05a343ac

Public Version Date

October 10, 2019

Public Version Number

1

DI Record Publish Date

October 02, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-