Duns Number:119193803
Device Description: ture assorted neon color combinations that add fun to their patented function. Like the or ture assorted neon color combinations that add fun to their patented function. Like the original Angle-Ease, the 12 locking angle positions allow them to meet every treatment and operator requirement.Reduce fatigue and ease wrist strain.Keep hands clear of the working field.Optimize suction hose path and efficiency.Rigid design provides full cheek retraction.Reversible for right- or left-side assisting.Tips fit all standard HVE valves. Single-use plastic construction in purple, green and orange color combinations
Catalog Number
70-42609
Brand Name
Angle-Ease Colorz Adjustable HVE Tips
Version/Model Number
70-42609
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
669cdd17-bd1e-4c98-9acd-9bcc24bc225d
Public Version Date
August 20, 2018
Public Version Number
1
DI Record Publish Date
July 18, 2018
Package DI Number
00723896009956
Quantity per Package
20
Contains DI Package
00723896009949
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 |