Duns Number:047741335
Device Description: Sterile Saline Wound Wash. Packaged in an aerosol (BOV) can.
Catalog Number
-
Brand Name
Discount Drug Mart
Version/Model Number
DDMWW
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
FQH
Product Code Name
Lavage, Jet
Public Device Record Key
77f76cad-bd9d-40cc-ada9-c3b81c8c32af
Public Version Date
May 04, 2020
Public Version Number
4
DI Record Publish Date
September 16, 2016
Package DI Number
10093351124379
Quantity per Package
48
Contains DI Package
00093351124372
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 | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |
| U | Unclassified | 1 |