Duns Number:796986144
Device Description: FIDUCIAL FM-4010 IMAGE 10MM GLOBAL AIMD
Catalog Number
-
Brand Name
Unibody™
Version/Model Number
FM-4010
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
K033619,K033619
Product Code
HAW
Product Code Name
Neurological stereotaxic Instrument
Public Device Record Key
3ee63400-129e-4f70-bb02-29dbcfb0dc29
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
November 17, 2015
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 | 102 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 20495 |
| 3 | A medical device with high risk that requires premarket approval | 3601 |