Duns Number:012430880
Device Description: Single Use Aerosol Evacuator
Catalog Number
5702441
Brand Name
Henry Schein
Version/Model Number
5702441
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)
Yes
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
16e9a890-1051-4394-9610-080c76a49804
Public Version Date
March 09, 2021
Public Version Number
1
DI Record Publish Date
March 01, 2021
Package DI Number
20304040142398
Quantity per Package
11
Contains DI Package
10304040142391
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 | 3829 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2579 |
| 3 | A medical device with high risk that requires premarket approval | 1 |
| U | Unclassified | 34 |