EarHugs for AccuScreen - INTELLIGENT HEARING SYSTEMS CORP.

Duns Number:154870455

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More Product Details

Catalog Number

-

Brand Name

EarHugs for AccuScreen

Version/Model Number

M015411

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

K073384,K073384,K073384

Product Code Details

Product Code

GWJ

Product Code Name

Stimulator, Auditory, Evoked Response

Device Record Status

Public Device Record Key

71c27480-5133-4fb7-a2c0-ab955b225c81

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

00817020029962

Quantity per Package

4

Contains DI Package

00817020029955

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"INTELLIGENT HEARING SYSTEMS CORP." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 86