Duns Number:103977526
Device Description: Reusable non-sterile extension for use with Universal Couchtop
Catalog Number
MTIL6602
Brand Name
Palliative Grid Extension
Version/Model Number
MTIL6602
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 02, 2017
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
K950068
Product Code
KXJ
Product Code Name
Table, radiologic
Public Device Record Key
f6e67c8e-bf50-4576-abcd-8fae8fd24da0
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 02, 2017
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 |