Duns Number:157565946
Device Description: MODULAR DRILL BIT, 3.2mm DIA. x 67mm X-LONG
Catalog Number
101-05-06
Brand Name
NA
Version/Model Number
101-05-06
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
K141797,K182346,K896601,K993082
Product Code
HWC
Product Code Name
Screw, fixation, bone
Public Device Record Key
8ee5f2ea-46bf-4f67-9583-d5e55adb9274
Public Version Date
August 26, 2022
Public Version Number
1
DI Record Publish Date
August 18, 2022
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 | 3717 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7206 |
| 3 | A medical device with high risk that requires premarket approval | 28 |