Duns Number:543265548
Catalog Number
-
Brand Name
KINGFA
Version/Model Number
KF-A F02(N)
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
K202107,K202107,K202107
Product Code
FXX
Product Code Name
Mask, Surgical
Public Device Record Key
56091527-66e8-4576-9344-696c94761fac
Public Version Date
February 08, 2021
Public Version Number
1
DI Record Publish Date
January 29, 2021
Package DI Number
26973163400100
Quantity per Package
40
Contains DI Package
16973163400103
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 2 |