Duns Number:126290993
Device Description: 6 electrodes, 13mm long, 0.4mm diameter disposable single subdermal needles
Catalog Number
-
Brand Name
Rhythmlink®
Version/Model Number
CTGN615
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
Yes
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
GXZ
Product Code Name
Electrode, Needle
Public Device Record Key
9a241e16-e198-4e51-91f9-dcba6cfad3ed
Public Version Date
April 19, 2022
Public Version Number
1
DI Record Publish Date
April 11, 2022
Package DI Number
10816312026136
Quantity per Package
6
Contains DI Package
00816312026139
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Product Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 453 |