Duns Number:355280827
Device Description: Examination and procedure table
Catalog Number
500-1015
Brand Name
Medstone
Version/Model Number
Medstone1 PM
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
IXR
Product Code Name
Table, Radiographic, Tilting
Public Device Record Key
5c6ecfa4-3265-4e0e-bb9a-52ebfd09de7e
Public Version Date
January 30, 2020
Public Version Number
1
DI Record Publish Date
January 22, 2020
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 | 1073 |
2 | A medical device with a moderate to high risk that requires special controls. | 17 |