Duns Number:016069284
Device Description: 60ml Luer Lock Hypodermic Syringe w/o Needle - Bulk Pack Tray
Catalog Number
2117
Brand Name
LiteTouch
Version/Model Number
2117
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
November 30, 2025
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K132553,K132553,K132553
Product Code
FMF
Product Code Name
Syringe, Piston
Public Device Record Key
586fd6ff-d5a1-4d08-a7f8-e311d893c114
Public Version Date
March 10, 2021
Public Version Number
5
DI Record Publish Date
December 26, 2019
Package DI Number
20732671221173
Quantity per Package
8
Contains DI Package
10732671121179
Package Discontinue Date
November 30, 2025
Package Status
In Commercial Distribution
Package Type
Corrugate Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 5 |