Duns Number:592534619
Device Description: Interventional Radiologists have requirement to carry out CT scans of patients for diagnos Interventional Radiologists have requirement to carry out CT scans of patients for diagnostic and interventional procedures on a patient. This could be on an Angiography Table (Cone Beam CT) or within a CT Scanner (Conventional CT). Minimising X-ray artefact for these procedures is appealing hence the requirement to elevate the patients arms cranially to clear their torso, the region of interest. Interventional Radiologists also have requirement to raise arms clear of the patients torso sides to allow access for biliary drainage procedures.This device aims to facilitate both imaging and patient access application.
Catalog Number
AM2000
Brand Name
Adept Medical Overhead Arm Support
Version/Model Number
AM2000
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
CCX
Product Code Name
Support, Patient Position
Public Device Record Key
dd34f28a-1e1f-45f2-9e8a-59c4d9095977
Public Version Date
September 21, 2020
Public Version Number
3
DI Record Publish Date
January 25, 2019
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 | 29 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 33 |