Tranquil II OTE - The Tranquil II OTE utilizes advanced digital - GENERAL HEARING INSTRUMENT, INC.

Duns Number:131229197

Device Description: The Tranquil II OTE utilizes advanced digital signal processing with broadband white or pi The Tranquil II OTE utilizes advanced digital signal processing with broadband white or pink noise integrated into a cosmetically appealing mini OTE case design. Designed for patients that suffer from Tinnitus

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More Product Details

Catalog Number

-

Brand Name

Tranquil II OTE

Version/Model Number

Tranquil II,OTE,10A,Digital,Beige,Pair

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

-

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

K061459

Product Code Details

Product Code

KLW

Product Code Name

Masker, Tinnitus

Device Record Status

Public Device Record Key

bd1d5165-a01b-4d9b-8452-00d2949c8307

Public Version Date

August 05, 2022

Public Version Number

4

DI Record Publish Date

September 28, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"GENERAL HEARING INSTRUMENT, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 60