Duns Number:527035248
Device Description: The piston syringe is a device intended for medical purposes, consisting of a calibrated h The piston syringe is a device intended for medical purposes, consisting of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male Luer Slip /lock connector (nozzle) for attaching the female Luer connector (hub) of a hypodermic single lumen needle, or for attaching other devices with a female Luer. The syringe is sterilized by EtO gas and is labeled Non-Pyrogenic. The device is intended for single use only.
Catalog Number
-
Brand Name
TKMD
Version/Model Number
TKSLL
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"
Yes
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
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
af5b1d85-34fa-4a63-a56c-48caff10702e
Public Version Date
November 13, 2020
Public Version Number
1
DI Record Publish Date
November 05, 2020
Package DI Number
16934841560045
Quantity per Package
100
Contains DI Package
06934841560048
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |