Duns Number:013799942
Device Description: Absorbent Tipped Applicator, Sterile
Catalog Number
-
Brand Name
Keystone Sterile Nasopharyngeal Non-Tapered Swab - 6 inch
Version/Model Number
KMSWAB-600P-100
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
KXG
Product Code Name
Applicator, Absorbent Tipped, Sterile
Public Device Record Key
6cdc36d0-b86e-4430-8b60-a551a91dc776
Public Version Date
August 25, 2021
Public Version Number
1
DI Record Publish Date
August 17, 2021
Package DI Number
90860000906091
Quantity per Package
100
Contains DI Package
90860000906084
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 | 16 |
2 | A medical device with a moderate to high risk that requires special controls. | 4 |