Duns Number:046189866
Device Description: 2.4MM X-LOCK CROSS-DRIVE SHORT BLADE
Catalog Number
24-1194
Brand Name
2.0/2.4MM FRACTURE SYSTEM
Version/Model Number
24-1194
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
-
Product Code
HXX
Product Code Name
Screwdriver
Public Device Record Key
4de80be7-6976-4057-8e92-ac86556e39cc
Public Version Date
October 05, 2018
Public Version Number
4
DI Record Publish Date
September 17, 2014
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 | 1783 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 11874 |
| 3 | A medical device with high risk that requires premarket approval | 34 |