Duns Number:791014871
Device Description: Surgical Mask, Level 2, Blue Earloop, NS
Catalog Number
1580
Brand Name
Dukal
Version/Model Number
1580
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K201421,K201421,K201421
Product Code
FXX
Product Code Name
Mask, surgical
Public Device Record Key
2b4bd7da-0aaf-4c3d-85b3-4f2cb30e3379
Public Version Date
May 23, 2022
Public Version Number
2
DI Record Publish Date
March 30, 2022
Package DI Number
20665973028891
Quantity per Package
12
Contains DI Package
10665973028894
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. | 31 |
| U | Unclassified | 1 |