Duns Number:039612668
Device Description: Light blue polypropylene Surgical Mask with ear loops and adjustable nose piece.
Catalog Number
S-10478
Brand Name
ULINE
Version/Model Number
S-10478
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"
-
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
K123787,K123787,K123787
Product Code
FXX
Product Code Name
Mask, Surgical
Public Device Record Key
826eee69-b349-4dfa-90f5-278bd830da26
Public Version Date
May 06, 2020
Public Version Number
4
DI Record Publish Date
January 23, 2017
Package DI Number
30851253007404
Quantity per Package
6
Contains DI Package
10851253007400
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 8 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |
| U | Unclassified | 2 |