Duns Number:081253414
Device Description: Spine Tabletop
Catalog Number
-
Brand Name
Domico Med-Device
Version/Model Number
32588
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
KXJ
Product Code Name
Table, Radiologic
Public Device Record Key
962514b3-f71f-4a47-b9ee-ef84f0d1a393
Public Version Date
January 24, 2020
Public Version Number
1
DI Record Publish Date
January 16, 2020
Package DI Number
10861001002649
Quantity per Package
1
Contains DI Package
00861001002642
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 512 |
2 | A medical device with a moderate to high risk that requires special controls. | 35 |