Duns Number:042126640
Device Description: single use, sterile pouched polyester spun swabs for specimen ciollection sampling from na single use, sterile pouched polyester spun swabs for specimen ciollection sampling from nasal area, i.e. Anterior nares
Catalog Number
-
Brand Name
Sterile Polyester Spun Swab 10 Pack
Version/Model Number
60578
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
a934723a-26dd-474b-bdb6-54c81cd07385
Public Version Date
October 11, 2022
Public Version Number
1
DI Record Publish Date
October 03, 2022
Package DI Number
00860004112747
Quantity per Package
1500
Contains DI Package
00850027193229
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 8 |