Duns Number:627572217
Device Description: PROCEDURE MASK, VISOR, ANTI-FOG, AQUA WITH EAR LOOPS, 160MM HG
Catalog Number
9002215
Brand Name
CUSTOMED
Version/Model Number
712057462215
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
K081633,K081633,K081633
Product Code
FXX
Product Code Name
Mask, Surgical
Public Device Record Key
f2a0a266-45b3-4eeb-af70-c3495933dc11
Public Version Date
May 06, 2020
Public Version Number
4
DI Record Publish Date
September 23, 2016
Package DI Number
M20890022152
Quantity per Package
4
Contains DI Package
M20890022151
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
25/BOX, 4BOX/CS
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7 |