Duns Number:246848147
Device Description: Disposable Face Shield
Catalog Number
MXFS-100
Brand Name
BetterShield™
Version/Model Number
MXFS-100
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HOY
Product Code Name
Shield, eye, ophthalmic (including sunlamp protective eyewear and post-mydriatic eyewear)
Public Device Record Key
44eb9559-9c78-4701-bed3-15208ac64a9c
Public Version Date
October 12, 2020
Public Version Number
1
DI Record Publish Date
October 02, 2020
Package DI Number
10620974002052
Quantity per Package
2
Contains DI Package
00620974002055
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 91 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 18 |
| 3 | A medical device with high risk that requires premarket approval | 2 |