Catalog Number

D1SP0001

Brand Name

PEDIGUARD THREADED

Version/Model Number

STARTER 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

-

Product Code

GAH

Product Code Name

Stylet, Surgical, General & Plastic Surgery

Public Device Record Key

bef40c32-fbf3-47e0-a9ee-8b4b0e85139c

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

December 26, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-