Duns Number:065762392
Device Description: Insulin Pen Needle 31G x 3/16"(5mm), Each
Catalog Number
-
Brand Name
Biotronix Healthcare Insulin Pen Needles
Version/Model Number
GE44004
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
February 28, 2030
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K133058,K133058,K133058
Product Code
FMF
Product Code Name
Syringe, Piston
Public Device Record Key
a472ebe2-c0cd-463c-bc8d-3ad240a35e31
Public Version Date
December 24, 2019
Public Version Number
2
DI Record Publish Date
September 29, 2019
Package DI Number
20858835007985
Quantity per Package
8
Contains DI Package
10858835007988
Package Discontinue Date
August 31, 2028
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 |