Catalog Number

101600; 101603

Brand Name

Bio-logic

Version/Model Number

Disposable Snap Electrodes

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K073626,K083371,K112247,K083371,K031009,K073626,K083371,K112247,K112247,K073626,K031009,K031009,K031009,K073626,K083371,K112247,K073626,K083371,K112247,K031009

Product Code

EWO

Product Code Name

Audiometer

Public Device Record Key

46e9cc32-c0a5-4552-a52c-6037ca92a259

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

December 30, 2016

Package DI Number

00382830001427

Quantity per Package

300

Contains DI Package

00382830008365

Package Discontinue Date

August 01, 2017

Package Status

Not in Commercial Distribution

Package Type

101603