Duns Number:486741981
Device Description: The drills with or without coupling for attachment to a power tool are re-usable rotary cu The drills with or without coupling for attachment to a power tool are re-usable rotary cutting instruments used in surgery for drilling cylindrical holes into bone. The cutting action is determined by the cutting edges.Two kind of coupling, permitting the connection with the power tool, exist: an AO coupling or a chuck coupling. A range of diameter and length is proposed.The drills are used with a power tool.
Catalog Number
T882
Brand Name
Drill little AO coupling Ø3 x 146 mm
Version/Model Number
T882
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
HTW
Product Code Name
Bit, Drill
Public Device Record Key
f4837b1b-8cc5-4c45-b28e-0d82b3a959ca
Public Version Date
August 19, 2020
Public Version Number
1
DI Record Publish Date
August 11, 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 | 299 |