Duns Number:004193103
Device Description: Castellini CA152 Pro-Tip Converter Kit Astek
Catalog Number
116345ASTEK
Brand Name
Astek
Version/Model Number
116345ASTEK
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
-
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
ECB
Product Code Name
UNIT, SYRINGE, AIR AND/OR WATER
Public Device Record Key
8bd6ed3c-42e4-45dc-a20f-1bc9af50c99c
Public Version Date
October 26, 2022
Public Version Number
1
DI Record Publish Date
October 18, 2022
Package DI Number
10843471151096
Quantity per Package
1
Contains DI Package
00843471151099
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Package
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 77 |
2 | A medical device with a moderate to high risk that requires special controls. | 38 |