Duns Number:006999528
Device Description: Blister Guard Spray in an Aerosol Can
Catalog Number
-
Brand Name
Kroger Blister Guard Spray
Version/Model Number
12785
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
NEC
Product Code Name
Bandage, Liquid, Skin Protectant
Public Device Record Key
cc8c7979-b8ac-4b88-b3c4-81875086dcfb
Public Version Date
July 06, 2021
Public Version Number
1
DI Record Publish Date
June 28, 2021
Package DI Number
10041260012782
Quantity per Package
48
Contains DI Package
00041260012785
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 | 13 |
2 | A medical device with a moderate to high risk that requires special controls. | 15 |