Duns Number:119193803
Device Description: Reduce number of hands needed, instruments used and procedure time! The Mirro-Vac Saliva E
Catalog Number
70-42615
Brand Name
Mirro-Vac Saliva Ejector Mirrors
Version/Model Number
70-42615
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
4119a83a-8d47-4d58-8545-f1bb0c764bab
Public Version Date
December 21, 2018
Public Version Number
2
DI Record Publish Date
July 18, 2018
Package DI Number
00723896010013
Quantity per Package
20
Contains DI Package
00723896010006
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 |