Duns Number:062388929
Device Description: Earloop Surgical Mask, blue, contains forming nosepiece, free of metal components, MRI com Earloop Surgical Mask, blue, contains forming nosepiece, free of metal components, MRI compatible, ASTM F2100 Level 3
Catalog Number
5313
Brand Name
Strong Manufacturers
Version/Model Number
5313
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
9d8a3e96-416d-4357-84df-22be50041afc
Public Version Date
January 29, 2021
Public Version Number
1
DI Record Publish Date
January 21, 2021
Package DI Number
10850005354717
Quantity per Package
300
Contains DI Package
00850005354710
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 |