Duns Number:338234588
Device Description: Accessory connects micro-motors to the console or other boards, thus allowing the control Accessory connects micro-motors to the console or other boards, thus allowing the control and functioning of the whole device.
Catalog Number
1601009-001
Brand Name
CABLE MX-i LED 3RD GEN
Version/Model Number
1601009-001
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
-
Product Code
EBW
Product Code Name
Controller, foot, handpiece and cord
Public Device Record Key
9b551c12-8414-43b3-b660-9bede29acb55
Public Version Date
October 26, 2022
Public Version Number
3
DI Record Publish Date
June 17, 2021
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 | 80 |