Duns Number:119193803
Device Description: Made from renewable, sustainable paper, ECOtip Earth-Friendly High Volume Evacuator Tips a Made from renewable, sustainable paper, ECOtip Earth-Friendly High Volume Evacuator Tips are the high-performance alternative to plastics. ECOtip is engineered and tested to provide outstanding stiffness, durability, and function. Food-grade coating eliminates moisture absorption and fraying during use. Tips fit standard HVE valves. Made under strict ISO standards from FDA-approved materials.
Catalog Number
71-08315
Brand Name
ECOtip HVE Tips Happy Teeth
Version/Model Number
10410010
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
eba10282-cc43-4354-9dad-bd0c8f7e1cba
Public Version Date
August 20, 2018
Public Version Number
1
DI Record Publish Date
July 19, 2018
Package DI Number
00723896010792
Quantity per Package
10
Contains DI Package
00723896010785
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 |