Duns Number:831375089
Device Description: Earloop Procedure Mask, ASTM Level 2, Green
Catalog Number
-
Brand Name
PremierPro
Version/Model Number
2452
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K123787,K123787
Product Code
FXX
Product Code Name
Mask, Surgical
Public Device Record Key
2df67af2-33ae-4272-b117-a7ba27265b5f
Public Version Date
January 04, 2021
Public Version Number
8
DI Record Publish Date
October 31, 2016
Package DI Number
10818566017366
Quantity per Package
6
Contains DI Package
00818566017369
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 | 486 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 177 |
| U | Unclassified | 1 |