Catalog Number

-

Brand Name

DR-HO'S

Version/Model Number

DH3001

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

KNP

Product Code Name

Orthosis, Corrective Shoe

Public Device Record Key

f88797f6-4d5d-4a45-9e0c-859833b3a2aa

Public Version Date

March 09, 2020

Public Version Number

1

DI Record Publish Date

March 01, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-