Catalog Number

-

Brand Name

AccuScreen

Version/Model Number

8-04-13965

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

-

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

GWJ

Product Code Name

Stimulator, Auditory, Evoked Response

Public Device Record Key

d88a0ef0-6115-492e-b11d-2ef18bd8f0fb

Public Version Date

May 03, 2021

Public Version Number

2

DI Record Publish Date

March 04, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-