Duns Number:008171162
Device Description: Insulin Pen Needle. Intended to be used with a pen injector device for the subcutaneous i Insulin Pen Needle. Intended to be used with a pen injector device for the subcutaneous injection of insulin.
Catalog Number
-
Brand Name
TechLITE PEN NEEDLES
Version/Model Number
232129
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
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FMI
Product Code Name
Needle, hypodermic, single lumen
Public Device Record Key
ba2b284b-6e35-4aef-93d3-a8e3a9ba2adf
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 23, 2016
Package DI Number
10015482232297
Quantity per Package
30
Contains DI Package
00015482232290
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case Pack
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 30 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 50 |