Catalog Number

5140-534-625

Brand Name

NA

Version/Model Number

5140-534-625

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

GWF

Product Code Name

STIMULATOR, ELECTRICAL, EVOKED RESPONSE

Public Device Record Key

9e0a4874-f15b-4082-b619-e7cd01f0eacf

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

December 23, 2016

Package DI Number

37613327298070

Quantity per Package

10

Contains DI Package

07613327298079

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

pack