Assure® - Ezairo RITE64/SIE64 Pearl White - HEARING LAB TECHNOLOGY, LLC

Duns Number:827693503

Device Description: Ezairo RITE64/SIE64 Pearl White

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More Product Details

Catalog Number

HLT-E-RITE64-PW

Brand Name

Assure®

Version/Model Number

3260

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 20, 2019

Issuing Agency

In GS1

Product Characteristics

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

ESD

Product Code Name

Hearing aid, air conduction

Device Record Status

Public Device Record Key

b348366c-03ea-48ff-b5bf-9c713049e96f

Public Version Date

October 06, 2020

Public Version Number

3

DI Record Publish Date

September 21, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"HEARING LAB TECHNOLOGY, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 138
2 A medical device with a moderate to high risk that requires special controls. 352