Duns Number:826499238
Device Description: SCREW, CROSSDRIVE, DRILL FREE, 3.5 MM TISSUE COLLAR, TI-6AL-4V
Catalog Number
-
Brand Name
LEVEL ONE ORTHOANCHOR
Version/Model Number
01-345-14-09
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 20, 2021
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
DZE
Product Code Name
IMPLANT, ENDOSSEOUS, ROOT-FORM
Public Device Record Key
f4830926-c7b6-4afd-8f1a-35143b59be34
Public Version Date
April 21, 2021
Public Version Number
8
DI Record Publish Date
March 24, 2016
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 | 7013 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4618 |