Duns Number:119193803
Device Description: The Protective Face Shield offers full-face protection with a soft, detachable elastic hea The Protective Face Shield offers full-face protection with a soft, detachable elastic headband. 1 1/4" thick permanently adhered foam pad supports the antifog shield over most eyewear and loupes. Wash with soap and water and allow to air dry. 10 per box.
Catalog Number
7039733
Brand Name
Practicon Face Shields
Version/Model Number
Practicon Face Shields
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)
-
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
4a3e4ce6-e8a4-4b9f-93d5-61c6d983744c
Public Version Date
July 21, 2020
Public Version Number
1
DI Record Publish Date
July 13, 2020
Package DI Number
00723896005033
Quantity per Package
100
Contains DI Package
00723896017654
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 | 93 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |