Catalog Number

359078

Brand Name

Protego

Version/Model Number

TD 75/18

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 23, 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

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

Yes

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

-

FDA Premarket Submission

P980023

Product Code

NVY

Product Code Name

Permanent defibrillator electrodes

Public Device Record Key

39a4c5c8-c5cc-48c8-9590-6e29c2e65bb0

Public Version Date

August 24, 2021

Public Version Number

5

DI Record Publish Date

August 22, 2014

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-