Duns Number:126290993
Device Description: 20 Paired Fine Wire Needle Electrodes, EMG, 50mm x 25g
Catalog Number
-
Brand Name
Rhythmlink®
Version/Model Number
221-222SS-550
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
726a7b40-22ef-4100-bbd3-1ef6efa5a263
Public Version Date
September 21, 2022
Public Version Number
1
DI Record Publish Date
September 13, 2022
Package DI Number
10816312026457
Quantity per Package
20
Contains DI Package
00816312026450
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| 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 |