Duns Number:016069284
Device Description: 60ml Luer Lock Hypodermic Syringe w/o Needle- Bulk Pack - Bags
Catalog Number
2017
Brand Name
Lite Touch
Version/Model Number
2017
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
March 06, 2026
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
e73a889c-6434-4c8b-bfc0-03f352d256e6
Public Version Date
March 15, 2021
Public Version Number
1
DI Record Publish Date
March 06, 2021
Package DI Number
10732671120172
Quantity per Package
20
Contains DI Package
00732671020178
Package Discontinue Date
March 06, 2026
Package Status
In Commercial Distribution
Package Type
Poly Bag
| 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 |