Duns Number:012430880
Device Description: Acclean Dental Pick Patient
Catalog Number
5702627
Brand Name
Henry Schein
Version/Model Number
5702627
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
JET
Product Code Name
PICK, MASSAGING
Public Device Record Key
6c21cef7-7770-4072-98ee-39f7074b0a8e
Public Version Date
May 17, 2021
Public Version Number
1
DI Record Publish Date
May 07, 2021
Package DI Number
20304040056053
Quantity per Package
12
Contains DI Package
10304040056056
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 |