Catalog Number

P1-AU412

Brand Name

PEDIGUARD CLASSIC

Version/Model Number

PEDIGUARD TRI TIP 3.2mm

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

K143159

Product Code

ETN

Product Code Name

Stimulator, Nerve

Public Device Record Key

b91f5da1-6d98-4ad5-974c-66db123f5a2f

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

August 22, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-