Duns Number:008965063
Device Description: WALG MIGRAINE HOT COLD EYE MASK
Catalog Number
-
Brand Name
WALGREENS
Version/Model Number
396767
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
IME
Product Code Name
Pack, Hot Or Cold, Reusable
Public Device Record Key
ee4de23b-c336-4ace-a1b2-04f8cd6bf8be
Public Version Date
July 13, 2020
Public Version Number
1
DI Record Publish Date
July 03, 2020
Package DI Number
10311917208234
Quantity per Package
12
Contains DI Package
00311917208237
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 75 |
2 | A medical device with a moderate to high risk that requires special controls. | 74 |
U | Unclassified | 2 |