Duns Number:078474365
Device Description: Earloop Procedure Masks, ASTM Level 2, Blue, Box
Catalog Number
5722011
Brand Name
Edge™ EarLoop Procedure Masks
Version/Model Number
5722011
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FXX
Product Code Name
Mask, Surgical
Public Device Record Key
327fad77-e3ad-4ba8-bd1f-d8d96209d4e5
Public Version Date
May 06, 2020
Public Version Number
2
DI Record Publish Date
February 06, 2020
Package DI Number
20818365020984
Quantity per Package
10
Contains DI Package
10818365020987
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 25 |
| U | Unclassified | 3 |