Duns Number:828690904
Device Description: Clear/Blue Saliva Ejectors, Phthalates-free, Flexible with smooth edges for maximum patien Clear/Blue Saliva Ejectors, Phthalates-free, Flexible with smooth edges for maximum patient comfort, Specially-designed tip ensures optimal suction
Catalog Number
1143002
Brand Name
PureLife Dental
Version/Model Number
1143002
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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"
Yes
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
DYN
Product Code Name
Mouthpiece, Saliva Ejector
Public Device Record Key
3d8148a3-3bd5-4b97-ac82-378700142620
Public Version Date
July 09, 2021
Public Version Number
1
DI Record Publish Date
July 01, 2021
Package DI Number
D79011430023
Quantity per Package
1000
Contains DI Package
D79011430021
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 | 4 |