Duns Number:089138159
Device Description: Sterile Saline Wound Wash. Packaged in an Aerosol (BOV) can.
Catalog Number
-
Brand Name
Premier Value
Version/Model Number
3012
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"
Yes
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
395bc97a-62d0-45f1-86c6-05a2664c4d70
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
June 23, 2017
Package DI Number
10840986030120
Quantity per Package
48
Contains DI Package
00840986030123
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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 5 |