Duns Number:078352849
Device Description: Periosteal Elevator Tunneling Kit used to lift/separate (elevate) or tunnel under the peri Periosteal Elevator Tunneling Kit used to lift/separate (elevate) or tunnel under the periosteum during surgery. Set of 8 Instruments.
Catalog Number
Periosteal Tunnel Kit
Brand Name
Periosteal Set Tunnel
Version/Model Number
Periosteal Tunneling Kit
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
EMJ
Product Code Name
Elevator, Surgical, Dental
Public Device Record Key
05da9057-3cba-4d28-b5f8-fd51488c0049
Public Version Date
April 20, 2022
Public Version Number
3
DI Record Publish Date
October 22, 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 | 405 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 536 |