Catalog Number

840667-0100

Brand Name

Bose Frames

Version/Model Number

BMD0007

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

HQY

Product Code Name

Sunglasses (Non-Prescription Including Photosensitive)

Public Device Record Key

3bce2c9a-d103-4589-988b-336c2762cab0

Public Version Date

January 24, 2022

Public Version Number

1

DI Record Publish Date

January 14, 2022

Package DI Number

10017817839515

Quantity per Package

8

Contains DI Package

00017817839518

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-