Catalog Number

HLT-E-RITE32-GR

Brand Name

Aspire

Version/Model Number

1260

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

ESD

Product Code Name

Hearing aid, air conduction

Public Device Record Key

e3b2aed5-4f5e-45a5-a890-82f027aaf682

Public Version Date

October 06, 2020

Public Version Number

2

DI Record Publish Date

November 26, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-