Duns Number:500731872
Catalog Number
018960
Brand Name
STERILE CBS HIGH SECURITY TISSUE 2 ML STRAW / BY 20
Version/Model Number
1
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 13, 2021
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
KJG
Product Code Name
Tube, Tissue Culture
Public Device Record Key
f0b4a788-a726-4a24-a05b-28a4d613aba5
Public Version Date
May 14, 2021
Public Version Number
2
DI Record Publish Date
December 07, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 2 |
2 | A medical device with a moderate to high risk that requires special controls. | 21 |