Catalog Number

2560-3

Brand Name

3M™ Red Dot™

Version/Model Number

2560-3

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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"

Yes

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

DRX

Product Code Name

Electrode, electrocardiograph

Public Device Record Key

665434bf-1e47-41f7-b56f-bd5f4f356a04

Public Version Date

August 02, 2018

Public Version Number

1

DI Record Publish Date

July 02, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-