Duns Number:024913248
Device Description: The EZ-Flow Anesthetic Delivery System is a device used for the injection of local anesthe The EZ-Flow Anesthetic Delivery System is a device used for the injection of local anesthetics for anesthesia administered prior to, or in conjunction with,dental procedures.
Catalog Number
-
Brand Name
EZ-Flow
Version/Model Number
EZ-Flow
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
-
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
EJI
Product Code Name
Syringe, Cartridge
Public Device Record Key
fe06d51c-4dbe-43fd-99c4-eba2f2783be6
Public Version Date
April 19, 2018
Public Version Number
1
DI Record Publish Date
March 19, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 13 |