Catalog Number

-

Brand Name

EMG Elect. w/Lead Wire Set, EP (1 set of 3/bag)

Version/Model Number

35700015S

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

-

Product Code

EXQ

Product Code Name

Cystometer, Electrical Recording

Public Device Record Key

81564710-0df8-4b5f-8cd9-beb925b687d1

Public Version Date

January 24, 2019

Public Version Number

1

DI Record Publish Date

December 24, 2018

Package DI Number

10890477000262

Quantity per Package

300

Contains DI Package

00890477000265

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-