Duns Number:065762392
Device Description: Blunt Fill Needle with Filters 18G x 1 1/2"
Catalog Number
GEBF5006
Brand Name
Biotronix Healthcare Blunt Fill Needles with Filters
Version/Model Number
GEBF5006
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GAA
Product Code Name
Needle, Aspiration And Injection, Disposable
Public Device Record Key
486c8260-31c5-4229-af47-af4b26be5d39
Public Version Date
December 24, 2019
Public Version Number
2
DI Record Publish Date
October 12, 2019
Package DI Number
20850005165310
Quantity per Package
10
Contains DI Package
10850005165313
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 | 9 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 65 |