Duns Number:791014871
Device Description: Surgical Mask, Level 3, Blue Earloop, Non-Sterile
Catalog Number
1590
Brand Name
Dukal
Version/Model Number
1590
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
K201732,K201732,K201732
Product Code
FXX
Product Code Name
Mask, surgical
Public Device Record Key
2bf59f4e-987a-415f-980d-1eb8d310cf64
Public Version Date
September 22, 2022
Public Version Number
1
DI Record Publish Date
September 14, 2022
Package DI Number
20665973029126
Quantity per Package
12
Contains DI Package
10665973029129
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 |