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 2 - Green
Catalog Number
209818
Brand Name
Medicom AssureMask
Version/Model Number
209818
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
f374abf0-73e9-4cce-af35-3ad9427d16bb
Public Version Date
April 28, 2022
Public Version Number
2
DI Record Publish Date
December 14, 2021
Package DI Number
20686864058179
Quantity per Package
4
Contains DI Package
10686864058172
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 |