Duns Number:243880700
Device Description: SAVEFACE Face Shield with Drape
Catalog Number
SF-8240
Brand Name
Batrik SAVEFACE Face Shield with Drape
Version/Model Number
SF-8240
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
ada20ffb-e2b7-4b65-a81d-5c62a12eaaa0
Public Version Date
February 04, 2022
Public Version Number
1
DI Record Publish Date
January 27, 2022
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 | 748 |
2 | A medical device with a moderate to high risk that requires special controls. | 20 |