Duns Number:809466410
Device Description: Micrometer for measuring Carbon Fiber Pins on Head Frame
Catalog Number
63MRL
Brand Name
Compass International
Version/Model Number
63MRL
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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"
Yes
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HAW
Product Code Name
Neurological Stereotaxic Instrument
Public Device Record Key
4d70f819-0618-45d7-b319-dd25ba73878e
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 08, 2016
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 | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 41 |