Duns Number:126290993
Device Description: 24 electrodes, 13mm long, 0.4mm diameter disposable single subdermal needles
Catalog Number
-
Brand Name
Rhythmlink®
Version/Model Number
CTGN115
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
e72abbef-03f6-4705-9201-a4ea1310586c
Public Version Date
October 23, 2020
Public Version Number
1
DI Record Publish Date
October 15, 2020
Package DI Number
10816312024132
Quantity per Package
24
Contains DI Package
00816312024135
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 |