Catalog Number

-

Brand Name

BIOPROTECH INC.

Version/Model Number

SG15R

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

K153019,K153019,K153019

Product Code

GXY

Product Code Name

Electrode, Cutaneous

Public Device Record Key

32c0c641-ecd5-4f71-bfb5-ec9cf0c017ca

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 18, 2016

Package DI Number

28809083940984

Quantity per Package

10

Contains DI Package

18809083940987

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Case