Duns Number:103977526
Device Description: For use with GE VCT Global 2000 CT
Catalog Number
MTIL630311
Brand Name
Lateral Stabilizer
Version/Model Number
MTIL630311
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 09, 2020
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
bf65e76c-91f1-4f00-a675-8a8a4812952a
Public Version Date
May 11, 2020
Public Version Number
7
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 |