Duns Number:268009609
Device Description: TWIST DRILL FOR ANCHOR BOLT, HEXAGONAL SHANK, LENGTH 160MM, ACCESSORY OF MICRODEEP DEPTH E TWIST DRILL FOR ANCHOR BOLT, HEXAGONAL SHANK, LENGTH 160MM, ACCESSORY OF MICRODEEP DEPTH ELECTRODE
Catalog Number
KIP-ACS-519
Brand Name
NA
Version/Model Number
DRILL AND STOP
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 17, 2022
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"
Yes
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
K170959
Product Code
GZL
Product Code Name
Electrode, Depth
Public Device Record Key
d0c41a24-1de7-4832-a9f4-be3b609a2df5
Public Version Date
October 21, 2022
Public Version Number
6
DI Record Publish Date
December 14, 2017
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 | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 108 |