Duns Number:796416191
Device Description: Drill 3.5mm Solid
Catalog Number
Z402P-275-35
Brand Name
Orthex Drill Solid
Version/Model Number
Z402P-275-35
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
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
KTT
Product Code Name
APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
Public Device Record Key
ae1252ef-00ee-4682-a01c-1ea1bffe8a76
Public Version Date
November 23, 2021
Public Version Number
2
DI Record Publish Date
March 02, 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 | 1662 |
2 | A medical device with a moderate to high risk that requires special controls. | 7273 |