Duns Number:932938897
Device Description: Sterile Cotton Roll (0.5 oz)
Catalog Number
L FZUSS 0005 R07201 FAB
Brand Name
First+Aid
Version/Model Number
L FZUSS 0005 R07201 FAB [was L FZUSS 0005 R07201 FBB]
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 17, 2022
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
FRL
Product Code Name
Fiber, Medical, Absorbent
Public Device Record Key
5f259e87-9eb7-46e1-9103-6eb225d108f9
Public Version Date
August 16, 2022
Public Version Number
3
DI Record Publish Date
February 28, 2020
Package DI Number
10048341007101
Quantity per Package
72
Contains DI Package
00048341007104
Package Discontinue Date
May 17, 2022
Package Status
Not 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 | 7 |