Catalog Number

D1PU0001

Brand Name

PEDIGUARD THREADED

Version/Model Number

DSG Pin 1

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

K152747

Product Code

PDQ

Product Code Name

Neurosurgical Nerve Locator

Public Device Record Key

8247dbd7-ca51-4789-854b-b75169e2392e

Public Version Date

June 10, 2022

Public Version Number

5

DI Record Publish Date

August 29, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-