Duns Number:611195173
Device Description: Men's Reader 2.5 x TORT-WD GRN- Magnifying Reading Glasses
Catalog Number
77025
Brand Name
Eagle Eyes
Version/Model Number
77025
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
HOI
Product Code Name
Spectacle, Magnifying
Public Device Record Key
4de5380a-42e5-4107-8f14-6b51fdc7f1cd
Public Version Date
August 09, 2021
Public Version Number
2
DI Record Publish Date
August 31, 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 | 245 |