Duns Number:256880576
Device Description: Medicom AssureMask Precision Surgery - Tie-on Surgical Face Mask with Visor and SureView T Medicom AssureMask Precision Surgery - Tie-on Surgical Face Mask with Visor and SureView Technology - Level 3 - Blue
Catalog Number
209915
Brand Name
Medicom AssureMask
Version/Model Number
209915
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)
Yes
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
8dcdd53c-7bc8-44ba-9a82-011fa0738fee
Public Version Date
April 28, 2022
Public Version Number
2
DI Record Publish Date
December 14, 2021
Package DI Number
20686864058186
Quantity per Package
4
Contains DI Package
10686864058189
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
outer case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 84 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 27 |
| U | Unclassified | 2 |