Duns Number:932938897
Device Description: Single Tip Polyester Swab, Plastic stick(S SWPET / S SWPET1 / S SWPET2 case pack variation Single Tip Polyester Swab, Plastic stick(S SWPET / S SWPET1 / S SWPET2 case pack variations)
Catalog Number
S SWPET 0170 R04801 USC
Brand Name
U.S. Cotton
Version/Model Number
S SWPET(x) 0170 R04801 USC
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 09, 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
KXF
Product Code Name
Applicator, Absorbent Tipped, Non-Sterile
Public Device Record Key
a65150c3-96f9-4d1c-a1f1-4c265ec809ec
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
February 13, 2021
Package DI Number
10048341011986
Quantity per Package
48
Contains DI Package
00048341011989
Package Discontinue Date
June 09, 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 |