Duns Number:216344051
Device Description: Protective Spray
Catalog Number
420200
Brand Name
SKIN-PREP 4oz Spray US
Version/Model Number
420200
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
3b230c90-b523-468f-98d8-598f30538c5a
Public Version Date
September 14, 2020
Public Version Number
1
DI Record Publish Date
September 04, 2020
Package DI Number
30040565111842
Quantity per Package
12
Contains DI Package
00040565111841
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 | 63 |
2 | A medical device with a moderate to high risk that requires special controls. | 126 |
U | Unclassified | 1 |