Duns Number:023904428
Device Description: INDICATOR, BIOLOGICAL STEAM SL
Catalog Number
-
Brand Name
McKesson
Version/Model Number
73-SCS100
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
FRC
Product Code Name
Indicator, Biological Sterilization Process
Public Device Record Key
d0d6819d-a2b9-449a-ad7c-1060c45b48e5
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
December 09, 2016
Package DI Number
40612479159165
Quantity per Package
4
Contains DI Package
20612479159154
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 | 870 |
2 | A medical device with a moderate to high risk that requires special controls. | 422 |
U | Unclassified | 44 |