Duns Number:932938897
Device Description: Cotton Roll (1 Lb)
Catalog Number
L GLDL 0001 R01201 US
Brand Name
U.S. Cotton
Version/Model Number
L GLDL 0001 R01201 US
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 03, 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
03c05ba5-36d6-491e-a2de-68030489ecbb
Public Version Date
January 04, 2022
Public Version Number
3
DI Record Publish Date
February 28, 2020
Package DI Number
10095859603103
Quantity per Package
12
Contains DI Package
00095859603106
Package Discontinue Date
January 03, 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 |