Duns Number:010968002
Device Description: 11.0MM/9.0MM TISSUE PROTECTOR
Catalog Number
03.333.702
Brand Name
Cannulated Compression Headless Screw
Version/Model Number
03.333.702
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
HXI
Product Code Name
PASSER, WIRE, ORTHOPEDIC
Public Device Record Key
d4cebec6-121d-412c-8175-a71c170075d9
Public Version Date
October 20, 2020
Public Version Number
3
DI Record Publish Date
June 13, 2019
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 |