Duns Number:017535668
Device Description: The PowrSyringe is a disposable, hand-held, 10mL injection syringe that incorporates ergon The PowrSyringe is a disposable, hand-held, 10mL injection syringe that incorporates ergonomic and mechanical advantages for fluid injection in a variety of medical procedures.
Catalog Number
-
Brand Name
PowrSyringe
Version/Model Number
PWR-10
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K072318,K072318,K072318
Product Code
FMF
Product Code Name
Syringe, Piston
Public Device Record Key
4f2449e2-f213-46eb-8355-97355ad268f6
Public Version Date
August 31, 2022
Public Version Number
1
DI Record Publish Date
August 23, 2022
Package DI Number
B090PWR101
Quantity per Package
1
Contains DI Package
B090PWR100
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shelf Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 24 |