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 1mL 30G x 1/2" (12mm)
Version/Model Number
260305
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
K153537,K153537,K153537,K153537
Product Code
FMF
Product Code Name
Syringe, Piston
Public Device Record Key
646a9fab-7bb5-4396-acac-3b516590049e
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
January 09, 2018
Package DI Number
10015482263055
Quantity per Package
10
Contains DI Package
00015482263058
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 |