Duns Number:006940423
Device Description: +2.50D• Classic frame-shape reading glasses,suitable for any occasion• Universal size fits +2.50D• Classic frame-shape reading glasses,suitable for any occasion• Universal size fits most face shapes• Reading glasses with spring hinge
Catalog Number
-
Brand Name
ViSAGE
Version/Model Number
51798
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 14, 2022
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HOI
Product Code Name
Spectacle, Magnifying
Public Device Record Key
afe5deb3-8e89-4f4e-a986-83531b305b6d
Public Version Date
September 14, 2022
Public Version Number
2
DI Record Publish Date
September 14, 2021
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 | 94 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |