Duns Number:314546664
Device Description: The iBEAM® evo Extension 415 is designed to support the patient’s head and neck region and The iBEAM® evo Extension 415 is designed to support the patient’s head and neck region and extends off the end of the iBEAM® evo Couchtop by 415 mm.
Catalog Number
P10105-412
Brand Name
iBEAM
Version/Model Number
P10105-412
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
ee5d2f86-e2f4-4a05-a810-f03d7ffbf3a1
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 |