Duns Number:102354446
Device Description: Midway Select Probe CP11 Single End Color Coded Standard Round Handle
Catalog Number
-
Brand Name
Midway Select
Version/Model Number
002-0659
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EIX
Product Code Name
Probe, Periodontic
Public Device Record Key
bb9999a8-f555-4085-8fff-a9ffd1f58042
Public Version Date
March 23, 2022
Public Version Number
1
DI Record Publish Date
March 15, 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 | 183 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 43 |