Duns Number:216344051
Device Description: Tincture of Benzoin Skin Prep Spray is a skin prep spray that enhances the adhesion of tap Tincture of Benzoin Skin Prep Spray is a skin prep spray that enhances the adhesion of tape/appliance while protecting sensitive skin from adhesives and body fluids.
Catalog Number
407000
Brand Name
Tincture of Benzoin Spray 4oz US
Version/Model Number
407000
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
FON
Product Code Name
Bag, Drainage, With Adhesive, Ostomy
Public Device Record Key
cfcf0166-06bc-4c87-90ca-d324fd199e3c
Public Version Date
September 14, 2020
Public Version Number
1
DI Record Publish Date
September 04, 2020
Package DI Number
30040565111828
Quantity per Package
12
Contains DI Package
00040565111827
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 |