Duns Number:010968002
Device Description: Ø1.5 / Ø2.0 / Ø2.5 Screw Caddy – Short Thread
Catalog Number
T009000070
Brand Name
Headed Screw System Instruments
Version/Model Number
T009000070
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
PXV
Product Code Name
General purpose instrument tray
Public Device Record Key
86c62898-b3ef-41e7-80b1-1ef4c6919887
Public Version Date
September 16, 2022
Public Version Number
5
DI Record Publish Date
January 14, 2020
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 | 440 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7793 |