Catalog Number

01-1500-0035

Brand Name

PediNail

Version/Model Number

01-1500-0035

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 29, 2021

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

HTJ

Product Code Name

GAUGE, DEPTH

Public Device Record Key

8dc62ac7-b589-46dd-b1ea-6146e198ac6e

Public Version Date

September 30, 2021

Public Version Number

3

DI Record Publish Date

August 15, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-