Catalog Number

130-00-223-00

Brand Name

Ponto

Version/Model Number

130-00-223-00

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 09, 2019

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

LXB

Product Code Name

Hearing Aid, Bone Conduction

Public Device Record Key

b5e2a313-2599-4597-ba93-0905b74cef57

Public Version Date

January 10, 2019

Public Version Number

3

DI Record Publish Date

September 09, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-