Duns Number:126290993
Device Description: 6 electrodes, 13mm long, 0.4mm diameter disposable single subdermal needle with touch proo 6 electrodes, 13mm long, 0.4mm diameter disposable single subdermal needle with touch proof connector
Catalog Number
-
Brand Name
Rhythmlink®
Version/Model Number
RLSP514
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 06, 2019
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
02e20b18-2291-459a-8232-834db8776d97
Public Version Date
September 10, 2019
Public Version Number
3
DI Record Publish Date
October 31, 2017
Package DI Number
10816312022770
Quantity per Package
6
Contains DI Package
00816312022773
Package Discontinue Date
-
Package Status
Not 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 |