Duns Number:010968002
Device Description: CANN COUNTERSINK FOR 6.5/7.5MM HEADED CANN SCREW + / LARGE QC
Catalog Number
03.333.214
Brand Name
Cannulated Screw System +
Version/Model Number
03.333.214
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
7f36a869-e945-40a3-b74c-34699b357687
Public Version Date
November 25, 2020
Public Version Number
2
DI Record Publish Date
May 21, 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 |