Catalog Number

041005JM

Brand Name

N/A

Version/Model Number

N/A

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

K181618

Product Code

NLH

Product Code Name

Catheter, Recording, Electrode, Reprocessed

Public Device Record Key

c08853aa-a0e9-4567-9668-b0472b9ec270

Public Version Date

April 29, 2019

Public Version Number

1

DI Record Publish Date

April 20, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-