Duns Number:117417828
Device Description: 10 mm x 14 mm Cannulated Drill Long and 10 mm Countersink (00850017962606 and 008500179625 10 mm x 14 mm Cannulated Drill Long and 10 mm Countersink (00850017962606 and 00850017962576)
Catalog Number
10-2014-S
Brand Name
S-Core™
Version/Model Number
10-2014-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
K162171,K162171
Product Code
HWC
Product Code Name
Screw, Fixation, Bone
Public Device Record Key
bee974e9-44b4-47ca-a6d0-e2c1c7a8f191
Public Version Date
May 16, 2022
Public Version Number
1
DI Record Publish Date
May 06, 2022
Package DI Number
10850017962580
Quantity per Package
10
Contains DI Package
00850017962583
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 59 |