Duns Number:487506230
Device Description: MP-Post root canal drill black, size 5
Catalog Number
MD.200004459
Brand Name
MP-POST
Version/Model Number
MD.200004459
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 27, 2020
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
EJL
Product Code Name
Bur, Dental
Public Device Record Key
74a8bbac-d06a-4d4c-84f5-37848ffb9c1c
Public Version Date
May 10, 2021
Public Version Number
4
DI Record Publish Date
February 22, 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 | 208 |
2 | A medical device with a moderate to high risk that requires special controls. | 535 |