Duns Number:126290993
Device Description: 4 electrode arrays, 10mm Disposable Quick Connect Deep Cup Electrode Array with extension 4 electrode arrays, 10mm Disposable Quick Connect Deep Cup Electrode Array with extension cable [25 Pack]
Catalog Number
-
Brand Name
Rhythmlink®
Version/Model Number
MRQD40606060715
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
8f203b61-fbf9-45dc-a45a-ae5a7904d731
Public Version Date
April 22, 2021
Public Version Number
1
DI Record Publish Date
April 14, 2021
Package DI Number
10816312024507
Quantity per Package
4
Contains DI Package
00816312024500
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 |