Duns Number:791014871
Device Description: DK Procedure Mask w/ear loop YEL NS
Catalog Number
1531
Brand Name
Dukal
Version/Model Number
1531
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 14, 2020
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
7f2c578e-ddff-416c-9c1b-257ead8b1592
Public Version Date
May 23, 2022
Public Version Number
10
DI Record Publish Date
September 24, 2016
Package DI Number
20665973004963
Quantity per Package
6
Contains DI Package
10665973004966
Package Discontinue Date
October 14, 2020
Package Status
Not 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 |