Duns Number:317654283
Device Description: Face Shield with Replacement Visors (Face Shield 10 pieces + Replacement Visors 20 pieces Face Shield with Replacement Visors (Face Shield 10 pieces + Replacement Visors 20 pieces )
Catalog Number
Z9070011
Brand Name
Face Shield with Replacement Visors
Version/Model Number
Z9070011
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
March 15, 2025
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
-
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
LYU
Product Code Name
ACCESSORY, SURGICAL APPAREL
Public Device Record Key
021a9d64-3eb8-447d-9054-b6801f75e329
Public Version Date
March 12, 2021
Public Version Number
2
DI Record Publish Date
June 19, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 35 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 979 |