Duns Number:244261462
Device Description: CS1-CH04,Contra Angle, Latch Type, CA Burs, 1:1
Catalog Number
-
Brand Name
MAXSO
Version/Model Number
SL2028
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
-
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
0ad22887-8253-4472-9070-1d47d34a40ce
Public Version Date
October 14, 2022
Public Version Number
1
DI Record Publish Date
October 06, 2022
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 150 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 17 |
| U | Unclassified | 6 |