Duns Number:146920025
Device Description: The Precision Stabilizer consists of one Trigger Head and two Stabilizer Arms.The Precisio The Precision Stabilizer consists of one Trigger Head and two Stabilizer Arms.The Precision Stabilizer is intended to provide a platform for devices that need a support mechanism in 3D space and it allows for 6-degrees of freedom to position the device in 3D space. One of it's intended uses is to provide a platform for use of an ultrasound transducer.
Catalog Number
-
Brand Name
Best Precision Stabilizer
Version/Model Number
6000
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"
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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
IWJ
Product Code Name
System, Applicator, Radionuclide, Manual
Public Device Record Key
ce6542a9-5780-477f-aa25-082486bf0eed
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
December 30, 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 | 35 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 15 |