Duns Number:311231554
Device Description: "St Marks Pudendal Electrode is a diagnostic tool for evaluationof patients with pelvic fl "St Marks Pudendal Electrode is a diagnostic tool for evaluationof patients with pelvic floor disorders, 30cm (12”) long, 12mm recording area "
Catalog Number
-
Brand Name
Alpine BioMed
Version/Model Number
9013L4402
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 28, 2020
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
GXY
Product Code Name
Electrode, Cutaneous
Public Device Record Key
f5543454-3de5-493d-914e-494c310212e7
Public Version Date
April 29, 2020
Public Version Number
5
DI Record Publish Date
October 13, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 191 |