Duns Number:126290993
Device Description: 3 electrode arrays, 10mm Disposable Quick Connect Deep Cup Electrode Array with extension 3 electrode arrays, 10mm Disposable Quick Connect Deep Cup Electrode Array with extension cable [25 Pack]
Catalog Number
-
Brand Name
Rhythmlink®
Version/Model Number
MRQD309070915
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
GXY
Product Code Name
Electrode, Cutaneous
Public Device Record Key
caa8f430-08a2-4cb6-8c09-87895f30ae86
Public Version Date
June 23, 2021
Public Version Number
1
DI Record Publish Date
June 15, 2021
Package DI Number
10816312025856
Quantity per Package
3
Contains DI Package
00816312025859
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 |