Duns Number:167102750
Device Description: Beesure Naturals Level 3 Face Mask 50 /BX , Canyon Red
Catalog Number
-
Brand Name
Bessure
Version/Model Number
BE2410
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"
Yes
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
a2880e02-47e5-43cd-b53c-9d8e563af0e7
Public Version Date
June 22, 2022
Public Version Number
3
DI Record Publish Date
December 07, 2021
Package DI Number
20817508020737
Quantity per Package
8
Contains DI Package
10817508020730
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 | 8 |