Duns Number:126290993
Device Description: MR Conditional Single PressOn Button Kit, 12, 1.5m Electrodes CG1
Catalog Number
-
Brand Name
Rhythmlink®
Version/Model Number
MRPB215
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)
Yes
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
996a9ead-88d8-4637-8bbb-f38101436541
Public Version Date
July 11, 2022
Public Version Number
1
DI Record Publish Date
July 01, 2022
Package DI Number
10816312026211
Quantity per Package
12
Contains DI Package
00816312026214
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 |