Duns Number:407522184
Catalog Number
1281.BSS
Brand Name
Replacement Backflush Needle with silicone tip, straight.
Version/Model Number
1281.BSS
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
-
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
GDM
Product Code Name
Needle, Aspiration And Injection, Reusable
Public Device Record Key
f2f65c52-9bd5-4e43-b055-bff83f3c2a26
Public Version Date
February 22, 2021
Public Version Number
2
DI Record Publish Date
February 02, 2021
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 | 203 |
2 | A medical device with a moderate to high risk that requires special controls. | 149 |