Duns Number:052054413
Device Description: Post Op Spectacle Fitover, Clear, Small
Catalog Number
-
Brand Name
Post Op Spectacle Fitover, Clear
Version/Model Number
62012-006
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 01, 2019
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
HQY
Product Code Name
Sunglasses (Non-Prescription Including Photosensitive)
Public Device Record Key
14727485-3496-4cb0-9db5-7402a88da843
Public Version Date
August 09, 2021
Public Version Number
3
DI Record Publish Date
April 08, 2019
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 | 28 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |
| 3 | A medical device with high risk that requires premarket approval | 65 |