Duns Number:065807495
Device Description: 3 Layer Surgical Mask, Level 3, Blue
Catalog Number
DMM-L3-A-BLU
Brand Name
StringKing
Version/Model Number
20221
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
K202607,K202607,K202607
Product Code
FXX
Product Code Name
Mask, Surgical
Public Device Record Key
b3652a67-b60a-4c82-ab0c-ee4d491ae890
Public Version Date
June 30, 2022
Public Version Number
2
DI Record Publish Date
September 09, 2021
Package DI Number
30195376202217
Quantity per Package
20
Contains DI Package
00195376202216
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 | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8 |