Duns Number:932938897
Device Description: Sterile Cotton Swabs (100ct)
Catalog Number
S FPDLRS 0100 R02401 FAB
Brand Name
First+Aid
Version/Model Number
S FPDLRS 0100 R02401 FAB [was S FPDLRS 0100 R02401 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
KXG
Product Code Name
Applicator, Absorbent Tipped, Sterile
Public Device Record Key
2499ec0e-9b80-4022-9e42-5ef4cd47a9d4
Public Version Date
February 04, 2021
Public Version Number
3
DI Record Publish Date
February 28, 2020
Package DI Number
10048341010774
Quantity per Package
24
Contains DI Package
00048341010777
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 |