Duns Number:847029543
Device Description: Spectacle Frame, Size 45-17-125
Catalog Number
LGLUCY0BBY0KIDS
Brand Name
Life Is Good
Version/Model Number
LG Lucy Blackberry
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HQR
Product Code Name
Apparatus, cautery, radiofrequency, ac-powered
Public Device Record Key
a8423c6f-de56-4f91-a7ad-e3fd29b12ad3
Public Version Date
October 17, 2019
Public Version Number
2
DI Record Publish Date
October 04, 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 | 232 |
2 | A medical device with a moderate to high risk that requires special controls. | 1353 |