Duns Number:695009476
Device Description: PRODUCT SUMMARYThis is used for insertion and removal of the ATOZ Mini-screw. The driver i PRODUCT SUMMARYThis is used for insertion and removal of the ATOZ Mini-screw. The driver is designed just for MK Mini-screw (MKS-1611, MKS-1613), so it does not fit other types of mini-screws.INDICATION FOR USEThis is used for insertion and removal of the ATOZ Mini-screwTRADE NAME ATOZ ScrewdriverMODEL NAME MKD-S and MKD-LCOSIST OFMKD-S *1EA + MKD-L*1EA
Catalog Number
-
Brand Name
ATOZ Screwdriver
Version/Model Number
MKD-L and MKD-S
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
NDP
Product Code Name
Accessories, Implant, Dental, Endosseous
Public Device Record Key
cbbe1e69-57b7-48b4-94e6-f1fb174903b7
Public Version Date
January 31, 2022
Public Version Number
1
DI Record Publish Date
January 22, 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 | 9 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6 |