Duns Number:008965063
Device Description: Hydrogel Burn Bandages, 2 Small Pads 0.98 IN x 2.20 IN (25 mm x 56 mm) and 2 Large Pads 1. Hydrogel Burn Bandages, 2 Small Pads 0.98 IN x 2.20 IN (25 mm x 56 mm) and 2 Large Pads 1.75 IN x 2.87 IN (44.5 mm x 73 mm)
Catalog Number
-
Brand Name
Well At Walgreens
Version/Model Number
973181
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"
Yes
For Single-Use
Yes
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
NAE
Product Code Name
Dressing, Wound, Hydrogel Without Drug And/Or Biologic
Public Device Record Key
77eca427-8053-4602-a862-1e86624f6f06
Public Version Date
July 22, 2020
Public Version Number
1
DI Record Publish Date
July 14, 2020
Package DI Number
10311917189571
Quantity per Package
12
Contains DI Package
00311917189574
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 |