Duns Number:119193803
Device Description: 2 locking angle adjustment positions, allowing it to meet every treatment and operator req 2 locking angle adjustment positions, allowing it to meet every treatment and operator requirement:Superior ergonomics and operator comfort—adjusts from a straight bayonet position to a 90° angle to easily reach any quadrant. Reduces fatigue and eases strain on the wrist by reducing hose tension and drag.Improved Visibility—offset approach keeps hands clear of the working field.Increased Efficiency—allows hose to slope downward from the valve for maximum suction efficiency.Full Retraction—rigid construction retracts cheeks just like standard tips.Reversible—accommodates either right or left-side assisting.Single-use white plastic tips fit all standard HVE valves.
Catalog Number
70-42610
Brand Name
Angle-Ease Adjustable HVE Tips
Version/Model Number
70-42610
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
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EHZ
Product Code Name
Evacuator, Oral Cavity
Public Device Record Key
7dd174f4-8acb-41da-93f6-52e40955b817
Public Version Date
August 20, 2018
Public Version Number
1
DI Record Publish Date
July 18, 2018
Package DI Number
00723896009970
Quantity per Package
20
Contains DI Package
00723896009963
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 93 |
2 | A medical device with a moderate to high risk that requires special controls. | 2 |