Duns Number:857278431
Device Description: 20° Posterior shade A3.5, mould 30M, U
Catalog Number
-
Brand Name
Myerson Special
Version/Model Number
T5468U030M
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
K924526
Product Code
ELM
Product Code Name
Denture, Plastic, Teeth
Public Device Record Key
255fff18-1f7e-4f29-9e85-caba0ebd2b40
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 24, 2016
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 | 134 |
2 | A medical device with a moderate to high risk that requires special controls. | 7702 |