Duns Number:381582196
Device Description: Universal sterile irrigation line enables the use of disinfectant solutions (chlorhexidine Universal sterile irrigation line enables the use of disinfectant solutions (chlorhexidine, sodium hypochlorite), or a saline solution for surgery.
Catalog Number
F57370
Brand Name
ACTEON
Version/Model Number
Universal sterile irrigation line
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
K072030
Product Code
EIA
Product Code Name
Unit, Operative Dental
Public Device Record Key
53acdf00-3f44-4084-af63-9298de4edcfd
Public Version Date
April 23, 2019
Public Version Number
5
DI Record Publish Date
September 24, 2016
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 | 8 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 416 |