Duns Number:103977526
Device Description: Reusable non-sterile couchtop for use with Accuray Robocouch
Catalog Number
MTIL3605
Brand Name
IPPS™ Couchtop
Version/Model Number
MTIL3605
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 17, 2019
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
K973842
Product Code
IXQ
Product Code Name
Table, radiographic, stationary top
Public Device Record Key
06a610de-8b59-41ec-883a-84a5605e5efc
Public Version Date
June 17, 2019
Public Version Number
3
DI Record Publish Date
May 02, 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 | 31 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1027 |