Duns Number:012430880
Device Description: Essentials earloop mask, ASTM level 2
Catalog Number
1382800
Brand Name
Henry Schein
Version/Model Number
1382800
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K123787,K123787,K123787
Product Code
FXX
Product Code Name
Mask, surgical
Public Device Record Key
8d78d781-7d37-40c6-bd5f-1d2f06b4fe8f
Public Version Date
January 04, 2021
Public Version Number
2
DI Record Publish Date
July 14, 2020
Package DI Number
20304040132399
Quantity per Package
40
Contains DI Package
10304040132392
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 | 3829 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2579 |
| 3 | A medical device with high risk that requires premarket approval | 1 |
| U | Unclassified | 34 |