Duns Number:065762392
Device Description: Disposable Hypodermic Needle 21G x 1 1/2
Catalog Number
GE36416
Brand Name
Biotronix Healthcare
Version/Model Number
GE36416
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
K050999,K050999,K050999
Product Code
FMI
Product Code Name
Needle, Hypodermic, Single Lumen
Public Device Record Key
e77ceeb4-523e-4d88-aee2-b4b04229a2e9
Public Version Date
December 24, 2019
Public Version Number
3
DI Record Publish Date
October 06, 2019
Package DI Number
20858835007039
Quantity per Package
100
Contains DI Package
10858835007032
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 |