Duns Number:103977526
Device Description: Extension for use with Universal Couchtop™ Long Extension on Varian TrueBeam™
Catalog Number
MTIL6670
Brand Name
Type-S™ Extension
Version/Model Number
MTIL6670
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
79b5ff47-af8f-4d17-ac04-7c945b1560fc
Public Version Date
April 10, 2020
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 |