Catalog Number

-

Brand Name

Bio Protech

Version/Model Number

NCS-SG15 (Lifelines)

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"

Yes

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

7ebf6441-e17e-48bb-9849-b7ae2218d68e

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 09, 2017

Package DI Number

10817120021115

Quantity per Package

25

Contains DI Package

00817120021118

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Box