Duns Number:932938897
Device Description: Cotton Balls (300ct Large Size)
Catalog Number
B GRDL 0300 R03606 FAB
Brand Name
First+Aid
Version/Model Number
B GRDL 0300 R03606 FAB [was B GRDL 0300 R03606 FBB]
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)
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
3dcd82b0-2b28-4124-9270-59f16c409b0c
Public Version Date
February 04, 2021
Public Version Number
3
DI Record Publish Date
February 28, 2020
Package DI Number
10048341007019
Quantity per Package
36
Contains DI Package
00048341007012
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 | 7 |