Duns Number:008171162
Device Description: Sterile Single-Use Pen Needle samples. Intended to be used with a pen injector device for Sterile Single-Use Pen Needle samples. Intended to be used with a pen injector device for the subcutaneous injection of insulin.
Catalog Number
-
Brand Name
TechLITE Pen Needle 4mm x 32g Sample 10's
Version/Model Number
234032
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
K143437,K143437
Product Code
FMI
Product Code Name
Needle, Hypodermic, Single Lumen
Public Device Record Key
77d85624-a3ff-4540-84a0-19c8bad58143
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
February 26, 2018
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 | 30 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 50 |