Duns Number:314546664
Device Description: Providing patient-specific immobilization for head and neck treatments often require a var Providing patient-specific immobilization for head and neck treatments often require a variety of immobilization devices. The Connexion™ Head and Neck Module provides a dedicated solution to support head and neck immobilization, by providing a common interface to not only Elekta immobilization devices, but also other commonly used third party accessories.
Catalog Number
P10105-213
Brand Name
Connexion
Version/Model Number
P10105-213
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
IXQ
Product Code Name
Table, Radiographic, Stationary Top
Public Device Record Key
026aac36-f691-4841-83ee-64baa5b9cb81
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
August 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 175 |