Duns Number:062388929
Device Description: Earloop surgical mask, blue, contains forming nosepiece (metal wire), ASTM F2100 Level 3
Catalog Number
5311
Brand Name
Strong Manufacturers
Version/Model Number
5311
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
-
Product Code
FXX
Product Code Name
Mask, Surgical
Public Device Record Key
38d6b74b-9f40-4565-b880-d7814bbac55a
Public Version Date
January 11, 2021
Public Version Number
1
DI Record Publish Date
January 01, 2021
Package DI Number
10850005354359
Quantity per Package
300
Contains DI Package
00850005354352
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 | 79 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 5 |