Catalog Number

2XBIS/BIS-17

Brand Name

2XBIS/BIS-17

Version/Model Number

2XBIS/BIS-17

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

K925168

Product Code

DTD

Product Code Name

Pacemaker Lead Adaptor

Public Device Record Key

997b15c5-1b95-4404-a055-916286a2f1c0

Public Version Date

February 05, 2021

Public Version Number

5

DI Record Publish Date

October 16, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-