Duns Number:078671236
Device Description: An x-ray system component intended to be mounted to the ceiling, to support and facilitate An x-ray system component intended to be mounted to the ceiling, to support and facilitate position of the x-ray tube. The OTC18M does not allow for synchronized tracking or stitching.
Catalog Number
-
Brand Name
Del Medical/Universal
Version/Model Number
OTC18M
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
IYB
Product Code Name
Tube Mount, X-Ray, Diagnostic
Public Device Record Key
adb580f8-40e7-4694-83b1-07ba9b0cc9ad
Public Version Date
April 25, 2022
Public Version Number
1
DI Record Publish Date
April 15, 2022
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 | 19 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 15 |