Catalog Number

D087024

Brand Name

IRVINE BIOMEDICAL INC.

Version/Model Number

D087024

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

K112232

Product Code

NLH

Product Code Name

CATHETER, RECORDING, ELECTRODE, REPROCESSED

Public Device Record Key

2e1e8d8e-f1b9-4a1b-849a-dfa3774aff54

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

November 03, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-