Catalog Number

BIOD6-08DR-002-RT-TB

Brand Name

NA

Version/Model Number

BIOD6-08DR-002-RT-TB

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"

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

K043513

Product Code

NLH

Product Code Name

CATHETER, RECORDING, ELECTRODE, REPROCESSED

Public Device Record Key

75eea6c5-652f-4506-88b9-0f64615735c9

Public Version Date

August 14, 2019

Public Version Number

4

DI Record Publish Date

September 22, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-