Catalog Number

HLT-SIE48WL-BK

Brand Name

Elevate

Version/Model Number

2360 WL

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 27, 2018

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

OSM

Product Code Name

Hearing aid, air conduction with wireless technology

Public Device Record Key

431138ae-f6c2-4fcb-8538-2cf9210e849e

Public Version Date

October 06, 2020

Public Version Number

4

DI Record Publish Date

December 19, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-