Duns Number:961027315
Device Description: Wound CleanserNo-rinse, non-irritating formulationNon-ionic surfactantDirections for use: Wound CleanserNo-rinse, non-irritating formulationNon-ionic surfactantDirections for use: 1. Turn nozzle to stream or spray position.2. Spray contents on area to be cleansed approximately 3 inches away.Ingredients: Purified water, poloxamer 188, sodium bicarbonate, sorbitol, citric acid, disodium EDTA, methylparaben, imidazolidinyl ureaIndications: May be used for the removal of foreign materials such as dirt and debris from dermal wounds.Caution: For external use only. Keep this and all similar products out of the reach of children.Store at ambient temperature.
Catalog Number
WC8OZ
Brand Name
CARDINAL HEALTH
Version/Model Number
WC8OZ
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
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
FRO
Product Code Name
Dressing, wound, drug
Public Device Record Key
47015e04-1b1a-4a5f-8ffa-736090823755
Public Version Date
May 24, 2019
Public Version Number
1
DI Record Publish Date
May 16, 2019
Package DI Number
10888499001343
Quantity per Package
12
Contains DI Package
00888499001346
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 | 101686 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 139430 |
| 3 | A medical device with high risk that requires premarket approval | 8 |
| U | Unclassified | 40 |