Duns Number:057728685
Device Description: (XTEX SF ISO PLUS PURE-WH)
Catalog Number
GPLUSWHSF
Brand Name
Crosstex International
Version/Model Number
GPLUSWHSF
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
808cda0b-aefc-4e3e-961a-90253dee7f25
Public Version Date
June 19, 2020
Public Version Number
4
DI Record Publish Date
February 11, 2017
Package DI Number
50732224120589
Quantity per Package
4
Contains DI Package
30732224120585
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
case
| 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 |