Duns Number:119193803
Device Description: Colorful Multi-Tips High Volume Evacuator Tips have a proven S-shaped end cut that increas Colorful Multi-Tips High Volume Evacuator Tips have a proven S-shaped end cut that increases patient comfort and conforms better to the natural profile of teeth. Combines vented and non-vented ends into a single inventory-reducing design
Catalog Number
70-8215
Brand Name
Multi-Tips HVE Tips
Version/Model Number
7001417
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
50797f7a-e46b-4d8a-88eb-4e9b6d98779c
Public Version Date
February 07, 2019
Public Version Number
1
DI Record Publish Date
January 07, 2019
Package DI Number
00723896010631
Quantity per Package
10
Contains DI Package
00723896010624
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 |