Duns Number:625272232
Device Description: Spike extender set, resistant to 80% DMSO, case of 24
Catalog Number
-
Brand Name
ABS Spike Adapter
Version/Model Number
ST-A
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)
Yes
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
b841f7b1-7efb-45cc-9976-b4c0e9903e59
Public Version Date
February 19, 2021
Public Version Number
3
DI Record Publish Date
September 23, 2016
Package DI Number
20816203021971
Quantity per Package
50
Contains DI Package
10816203021974
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 22 |
2 | A medical device with a moderate to high risk that requires special controls. | 18 |
U | Unclassified | 44 |