Catalog Number

KB0961

Brand Name

BioKnit Conductive Garment

Version/Model Number

KB0961 univ. cervical

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

-

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

K053214

Product Code

GXY

Product Code Name

Electrode, Cutaneous

Public Device Record Key

40c947e1-45ce-46a4-925b-5b2ec47ea324

Public Version Date

February 19, 2021

Public Version Number

5

DI Record Publish Date

September 23, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-