Duns Number:057728685
Device Description: Cotton Rolls Non-Sterile, #2 Medium 1.5"x.375"/4x1 cm
Catalog Number
-
Brand Name
Cotton Rolls
Version/Model Number
DNC
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
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EFN
Product Code Name
COTTON, ROLL
Public Device Record Key
dd096a40-9326-46f9-a7a5-c3f22e15569a
Public Version Date
September 02, 2022
Public Version Number
1
DI Record Publish Date
August 25, 2022
Package DI Number
50732224004063
Quantity per Package
12
Contains DI Package
10732224000043
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 33 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 25 |