Catalog Number

M52322

Brand Name

Ponto

Version/Model Number

M52322

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 15, 2017

Issuing Agency

In GS1

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

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

LXB

Product Code Name

Hearing Aid, Bone Conduction

Public Device Record Key

f8c4417b-c36c-4b73-bc06-b588243834a8

Public Version Date

October 16, 2020

Public Version Number

3

DI Record Publish Date

September 16, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-