Duns Number:012430880
Device Description: Acclean BCA Prophy Angle Pink Soft Pink
Catalog Number
9004270
Brand Name
Henry Schein
Version/Model Number
9004270
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"
Yes
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
EGS
Product Code Name
Handpiece, contra- and right-angle attachment, dental
Public Device Record Key
689a4c3d-3460-428f-9aa1-2d203300d963
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
November 01, 2017
Package DI Number
20304040060135
Quantity per Package
24
Contains DI Package
10304040060138
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| 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 |