Catalog Number

-

Brand Name

Model 4625 ACUITY® X4 Connector Tool

Version/Model Number

4625

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

P910073

Product Code

NVY

Product Code Name

Permanent defibrillator electrodes

Public Device Record Key

b2a6f941-3a21-442d-8329-ea00f58f2351

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

February 09, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-