Catalog Number

XI.D-A

Brand Name

XI.D-A™

Version/Model Number

XI.D-A

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 03, 2020

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

K070926,K070926

Product Code

IKD

Product Code Name

CABLE, ELECTRODE

Public Device Record Key

830a51c8-0856-4afa-989c-8f2d58aadee1

Public Version Date

December 03, 2020

Public Version Number

5

DI Record Publish Date

November 18, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-