Duns Number:932938897
Device Description: Sterile Cotton Roll (16 oz)
Catalog Number
L FZUSS 0160 R01201 US
Brand Name
U.S. Cotton
Version/Model Number
L FZUSS 0160 R01201 US
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 19, 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
db45519d-e29a-4511-9512-773e065a1e42
Public Version Date
September 21, 2022
Public Version Number
2
DI Record Publish Date
February 28, 2020
Package DI Number
10095859100169
Quantity per Package
12
Contains DI Package
00095859100162
Package Discontinue Date
August 19, 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 |