Duns Number:102354446
Device Description: Midway Select Disposable Diamonds 856L-016F Pkg/25
Catalog Number
-
Brand Name
Midway Select
Version/Model Number
002-0574
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
DZP
Product Code Name
Instrument, Diamond, Dental
Public Device Record Key
e3e2632b-0549-4c8c-9353-2cd763d710a0
Public Version Date
March 12, 2021
Public Version Number
1
DI Record Publish Date
March 04, 2021
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 | 183 |
2 | A medical device with a moderate to high risk that requires special controls. | 43 |