Duns Number:024913248
Device Description: The Acuflow Anesthetic Delivery System is a device used for injection of local anesthetics The Acuflow Anesthetic Delivery System is a device used for injection of local anesthetics for anesthesia administered prior to, or in conjunction with, dental procedure.
Catalog Number
-
Brand Name
Acuflow
Version/Model Number
Acuflow
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
-
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
-
Product Code Name
-
Public Device Record Key
17ce7de2-849b-4569-8abc-d69204d7cb15
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 |