Duns Number:486711679
Device Description: 2.4MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE 30MM STERILE
Catalog Number
201780TS
Brand Name
NA
Version/Model Number
201.780TS
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
K112583,K002271,K050110,K063049,K102694
Product Code
HRS
Product Code Name
Plate, fixation, bone
Public Device Record Key
1d5a2ef5-4b26-47fd-82dd-ca06225565bd
Public Version Date
May 02, 2022
Public Version Number
4
DI Record Publish Date
March 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 | 8630 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 16671 |
| U | Unclassified | 2 |