Duns Number:012430880
Device Description: Saliva Ejector White w/Pnk Tip
Catalog Number
1125996
Brand Name
Henry Schein
Version/Model Number
1125996
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
DYN
Product Code Name
Mouthpiece, saliva ejector
Public Device Record Key
d6a792e3-39b5-46f1-91df-49b114f9263a
Public Version Date
February 11, 2019
Public Version Number
1
DI Record Publish Date
January 11, 2019
Package DI Number
20304040040182
Quantity per Package
10
Contains DI Package
10304040040185
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 |