Catalog Number

-

Brand Name

waveguard

Version/Model Number

XE-385.C

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 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

K110223

Product Code

GXY

Product Code Name

ELECTRODE, CUTANEOUS

Public Device Record Key

8a547388-ed66-4069-8d58-237abf874bd1

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

July 10, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-