Duns Number:004022104
Device Description: Diamond Gen. 2 Hex Drive Fixed Screw, 4.0 x 18mm
Catalog Number
-
Brand Name
DIAMOND
Version/Model Number
6-F-4018
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 08, 2021
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
KWQ
Product Code Name
Appliance, Fixation, Spinal Intervertebral Body
Public Device Record Key
c9743d3a-3c35-45de-b264-44ac1ef9e5d3
Public Version Date
December 09, 2021
Public Version Number
6
DI Record Publish Date
May 23, 2017
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 | 1993 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3642 |
| U | Unclassified | 15 |