Duns Number:079767953
Device Description: 200 Sterile 6" Cotton Tip Applicator
Catalog Number
4305x1+st
Brand Name
Avaline Medical NJ LLC
Version/Model Number
4305x1+st
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"
Yes
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
KXF
Product Code Name
APPLICATOR, ABSORBENT TIPPED, NON-STERILE
Public Device Record Key
cb175040-fc80-48a7-8902-e6d5bb8d0714
Public Version Date
March 14, 2022
Public Version Number
1
DI Record Publish Date
March 05, 2022
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 263 |