Duns Number:791014871
Device Description: DK Surgical Mask w/tie BL NS
Catalog Number
1540
Brand Name
Dukal
Version/Model Number
1540
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
K070407,K070407,K070407
Product Code
FXX
Product Code Name
Mask, surgical
Public Device Record Key
7f37612c-b549-4ca9-9863-7382d2920c3f
Public Version Date
May 23, 2022
Public Version Number
11
DI Record Publish Date
September 24, 2016
Package DI Number
20665973004970
Quantity per Package
6
Contains DI Package
10665973004973
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 |