Duns Number:002579431
Device Description: Bose Frames (Alto) is a pair of non-prescription sunglasses (with Rx option in US) deliver Bose Frames (Alto) is a pair of non-prescription sunglasses (with Rx option in US) delivering an open ear audio experience to the customer.
Catalog Number
833416-0100
Brand Name
Bose Frames
Version/Model Number
BMD0005
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
fb61c3cc-2242-4371-a985-9b91b65c9337
Public Version Date
August 09, 2021
Public Version Number
2
DI Record Publish Date
September 30, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 16 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |