Catalog Number

69

Brand Name

LE BioSleeve

Version/Model Number

7

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 10, 2017

Issuing Agency

In HIBCC

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

K141342

Product Code

GXY

Product Code Name

Electrode, Cutaneous

Public Device Record Key

4754547f-13f2-4380-b8e9-f4c80784ff5e

Public Version Date

February 19, 2021

Public Version Number

4

DI Record Publish Date

September 24, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-