Duns Number:835233107
Device Description: AXIEM KIT 9732661 PORTABLE 110
Catalog Number
-
Brand Name
StealthStation Treon AxiEM
Version/Model Number
9732661
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
-
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
HAW
Product Code Name
Neurological stereotaxic Instrument
Public Device Record Key
364a8e44-8cbb-4249-b1b3-8e5efe112c0b
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
May 23, 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 | 23 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1961 |
| 3 | A medical device with high risk that requires premarket approval | 1 |