Duns Number:126290993
Device Description: 25 Ground/Reference Needle Electrodes, EMG, 12mm x 28g
Catalog Number
-
Brand Name
Rhythmlink
Version/Model Number
121-812-24TP
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
IKT
Product Code Name
Electrode, Needle, Diagnostic Electromyograph
Public Device Record Key
56497efd-dfd5-4000-9f07-8a73d19f3878
Public Version Date
September 02, 2022
Public Version Number
1
DI Record Publish Date
August 25, 2022
Package DI Number
10816312024842
Quantity per Package
25
Contains DI Package
00816312024845
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 |