Catalog Number

63043-E

Brand Name

PRO AKUSTIK

Version/Model Number

PRO AKUSTIK IPRO 2.5 AI RIC R (Right)

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

-

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

KLW

Product Code Name

Masker, tinnitus

Public Device Record Key

50d7b2bd-886f-4958-b5c1-f5eb5482d87d

Public Version Date

October 06, 2020

Public Version Number

2

DI Record Publish Date

March 11, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-