Duns Number:832637081
Device Description: CALIBRATED TAP FOR 2.4MM CORTEX SCREWS W/HEX COUPLING
Catalog Number
311242
Brand Name
NA
Version/Model Number
311.242
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 01, 2018
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
K150796
Product Code
DZJ
Product Code Name
DRIVER, WIRE, AND BONE DRILL, MANUAL
Public Device Record Key
645d12cf-413a-40de-bf8c-8c3e954530c5
Public Version Date
December 03, 2018
Public Version Number
5
DI Record Publish Date
June 30, 2016
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 | 1194 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4171 |
| 3 | A medical device with high risk that requires premarket approval | 30 |
| U | Unclassified | 1 |