Duns Number:314546664
Device Description: HeadFIX® Saliva Stop is connected between the vacuum pump and the mouthpiece preventing s HeadFIX® Saliva Stop is connected between the vacuum pump and the mouthpiece preventing saliva from reaching the vacuum pump.
Catalog Number
P10103-309
Brand Name
HeadFIX
Version/Model Number
P10103-309
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 28, 2020
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
IYE
Product Code Name
Accelerator, Linear, Medical
Public Device Record Key
f8f68065-74b8-446e-81c6-1bc6f9f1ee3b
Public Version Date
August 31, 2020
Public Version Number
3
DI Record Publish Date
August 23, 2016
Package DI Number
04056719000370
Quantity per Package
10
Contains DI Package
04056719001803
Package Discontinue Date
August 28, 2020
Package Status
Not in Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 175 |