Duns Number:006309355
Device Description: Sample, Denticator Eco Slim Snap On, DPA
Catalog Number
295489
Brand Name
Sample, Denticator Eco Slim Snap On, DPA
Version/Model Number
295489
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
deb2e27e-ff96-4c0f-b5c7-ae9409eb289e
Public Version Date
October 05, 2022
Public Version Number
3
DI Record Publish Date
November 06, 2019
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 | 138 |
2 | A medical device with a moderate to high risk that requires special controls. | 85 |