Duns Number:149818952
Device Description: Screw, 5mm, Burr Hole Cover
Catalog Number
6015
Brand Name
GUARDIAN™
Version/Model Number
6015
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
GXR
Product Code Name
COVER, BURR HOLE
Public Device Record Key
f53f23db-aba1-4ebe-81e6-03aa2cac2074
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 30, 2016
Package DI Number
15414734403075
Quantity per Package
5
Contains DI Package
05414734403078
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 70 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1429 |
| 3 | A medical device with high risk that requires premarket approval | 736 |