Duns Number:076404432
Device Description: ASTM Level 3 Earloop Mask, Violet 50 pcs box
Catalog Number
-
Brand Name
Resilient Medical Solutions
Version/Model Number
RMEM3
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
FXX
Product Code Name
Mask, Surgical
Public Device Record Key
ae9705be-f9c8-418a-8b7d-6604c2251bd5
Public Version Date
June 22, 2022
Public Version Number
1
DI Record Publish Date
June 14, 2022
Package DI Number
10850037100061
Quantity per Package
10
Contains DI Package
00850037100064
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
case
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 9 |