Duns Number:010968002
Device Description: CANN COUNTERSINK FOR 6.5/7.5MM CANN HEADLESS SCR/LARGE QC LNG
Catalog Number
03.333.205S
Brand Name
Cannulated Compression Headless Screw
Version/Model Number
03.333.205S
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
f26d18b0-e03d-4cc2-bf33-f9614350e9bc
Public Version Date
November 04, 2020
Public Version Number
2
DI Record Publish Date
October 24, 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 |