Duns Number:126290993
Device Description: 24 electrodes, 7mm long, 0.4mm diameter disposable single subdermal needle with touch proo 24 electrodes, 7mm long, 0.4mm diameter disposable single subdermal needle with touch proof connector
Catalog Number
-
Brand Name
Rhythmlink®
Version/Model Number
RLSND107-2.5
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
9573a3f0-ed3b-4fe2-b7bd-cd1e7a56ae73
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 17, 2016
Package DI Number
10816312020011
Quantity per Package
24
Contains DI Package
00816312020014
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 |