Duns Number:057728685
Device Description: ConFirm™ Premium Test Service Mail-in Sterilizer Indicators Monitoring Service, 12 Tests ( ConFirm™ Premium Test Service Mail-in Sterilizer Indicators Monitoring Service, 12 Tests (3 Strip Test, 2 Tests & 1 Control Strip)
Catalog Number
CST120
Brand Name
Crosstex International
Version/Model Number
CST120
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
K023716,K023716,K023716
Product Code
FRC
Product Code Name
Indicator, biological sterilization process
Public Device Record Key
c61db10f-7710-404c-bad0-22f25a98f114
Public Version Date
April 13, 2020
Public Version Number
2
DI Record Publish Date
September 04, 2019
Package DI Number
50732224000409
Quantity per Package
6
Contains DI Package
10732224000401
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 |