Duns Number:126290993
Device Description: 10 probes, 200mm long, 1.85-2.5mm diameter, 2.3mm ball tip pedicle screw stimulating probe 10 probes, 200mm long, 1.85-2.5mm diameter, 2.3mm ball tip pedicle screw stimulating probe with touch proof connector
Catalog Number
-
Brand Name
Rhythmlink®
Version/Model Number
RLBTP200-2.5
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
ETN
Product Code Name
Stimulator, Nerve
Public Device Record Key
01f8ebc7-07b0-4a34-9e46-9928f9d8c2ef
Public Version Date
April 05, 2022
Public Version Number
3
DI Record Publish Date
September 17, 2016
Package DI Number
10816312020868
Quantity per Package
10
Contains DI Package
00816312020861
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 |