Duns Number:103977526
Device Description: For IBA, L-Series, with Lok-Bar™ and rectangular extension
Catalog Number
MTIL6841
Brand Name
Universal Couchtop™
Version/Model Number
MTIL6841
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
K180021
Product Code
IXQ
Product Code Name
Table, radiographic, stationary top
Public Device Record Key
0ea2f077-0134-406f-beb0-6534ae34c6f3
Public Version Date
March 27, 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 |