Duns Number:103977526
Device Description: trUpoint ARCH™ compatible extension for use with Universal Couchtop™ Long Extension on Var trUpoint ARCH™ compatible extension for use with Universal Couchtop™ Long Extension on Varian TrueBeam™
Catalog Number
MTIL6671
Brand Name
Posifix® Extension
Version/Model Number
MTIL6671
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
K060737,K180021
Product Code
IXQ
Product Code Name
Table, radiographic, stationary top
Public Device Record Key
64de2706-1dd3-427e-b6fc-a7876ccd1772
Public Version Date
January 08, 2021
Public Version Number
3
DI Record Publish Date
August 20, 2018
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 | 31 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1027 |