Duns Number:010968002
Device Description: CANN COUNTERSINK FOR 3.5MM/4.0MM CANN HEADLESS SCREW/QC
Catalog Number
03.333.202
Brand Name
Cannulated Compression Headless Screw
Version/Model Number
03.333.202
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
-
Product Code
LXH
Product Code Name
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Public Device Record Key
293f337c-f1d1-47af-a8ad-7a2a8dbf7dab
Public Version Date
July 17, 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 |