Duns Number:047741335
Device Description: Wound Wash, 8 FL OZ (240 mL)
Catalog Number
-
Brand Name
Discount Drug Mart Food Fair
Version/Model Number
093351012709
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
FRO
Product Code Name
Dressing, Wound, Drug
Public Device Record Key
e63ceede-de85-496f-aeaa-8acdf11beda2
Public Version Date
April 21, 2021
Public Version Number
1
DI Record Publish Date
April 13, 2021
Package DI Number
20093351012703
Quantity per Package
12
Contains DI Package
00093351012709
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 |