Duns Number:506826739
Device Description: PPS Periosteal elevator "Bernotti"for tunnel procedures 3 mmF-LINE SL double end PPS Periosteal elevator "Bernotti"for tunnel procedures 3 mmF-LINE SL double ended
Catalog Number
-
Brand Name
devemed
Version/Model Number
PPS 1010 F
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
-
Product Code
HTE
Product Code Name
Elevator
Public Device Record Key
b7f7f553-f546-4e3d-a0ee-b76cfc9ee2c7
Public Version Date
December 04, 2020
Public Version Number
2
DI Record Publish Date
April 03, 2020
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 | 2521 |