Duns Number:057728685
Device Description: (SEC.FIT U.SENS/FF-W/VSR)
Catalog Number
GCPWSSF
Brand Name
Crosstex International
Version/Model Number
GCPWSSF
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)
-
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
ea2c0418-c3e6-44a5-b7f6-ee2b689ab204
Public Version Date
June 19, 2020
Public Version Number
4
DI Record Publish Date
November 11, 2016
Package DI Number
30732224120479
Quantity per Package
16
Contains DI Package
10732224120475
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 33 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 25 |