Duns Number:317654283
Device Description: Face Shield with Replacement Visors class II (Face Shie Face Shield with Replacement Visors class II (Face Shield 10 pieces +
Catalog Number
Z9070013
Brand Name
Face Shield with Replacement Visors
Version/Model Number
Z9070013
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)
-
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
7f626da0-4a82-40dd-b7f4-2fccabc2da6a
Public Version Date
March 12, 2021
Public Version Number
2
DI Record Publish Date
August 04, 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 |