Duns Number:078671236
Device Description: The DM-OTC18M is the version of the DMX system which uses an overhead tube crane and does The DM-OTC18M is the version of the DMX system which uses an overhead tube crane and does not perform synchronized tracking or stitching. This x-ray system can perform a comprehensive range of radiographic procedures.
Catalog Number
-
Brand Name
DMX System
Version/Model Number
DM-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"
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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
KPR
Product Code Name
System, X-Ray, Stationary
Public Device Record Key
8d3eeea9-d338-4936-8131-0340d951431a
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 |