Catalog Number

LBO00001B2

Brand Name

Lexie B2, Powered by Bose

Version/Model Number

LB2001

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"

Yes

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K211008

Product Code

QDD

Product Code Name

Self-Fitting Air-Conduction Hearing Aid

Public Device Record Key

db6aeb77-43ee-4acd-8373-35908b6beee8

Public Version Date

September 19, 2022

Public Version Number

1

DI Record Publish Date

September 09, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-