Duns Number:008171162
Device Description: TechLITe Insulin Syringe with fixed needle is a sterile single use syringe for the injecti TechLITe Insulin Syringe with fixed needle is a sterile single use syringe for the injection of U-100 insulin only.
Catalog Number
-
Brand Name
TechLITE Insulin Syringes 0.3mL 30G x 1/2" (12mm)
Version/Model Number
260301
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
FMF
Product Code Name
Syringe, Piston
Public Device Record Key
727b4610-2447-4cc9-b48c-862ca9770e8d
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
January 09, 2018
Package DI Number
10015482263017
Quantity per Package
10
Contains DI Package
00015482263010
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Master Shipper
| 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 |