Catalog Number

414015

Brand Name

Protego DF-1

Version/Model Number

SD 65/16

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 05, 2022

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

14ea1844-683d-4aa4-a0a2-1c8b273cd722

Public Version Date

October 06, 2022

Public Version Number

5

DI Record Publish Date

December 03, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-