Duns Number:531408342
Device Description: The non sterile Peña Muscle Stimulator Bipolar Probe (PS2P) is a 17 cm long reusable probe The non sterile Peña Muscle Stimulator Bipolar Probe (PS2P) is a 17 cm long reusable probe for use in the surgical treatment of high and low anorectal malformation. The probe has a 260 cm cord with two electrically shrouded banana plugs for attachment to the Peña Muscle Stimulator (PS2, sold separately). The probe tip consists of two gold plated polished wire probes, 0.8 mm diameter and separated by 1.8 mm. The wire probes function as the bipolar stimulus electrodes when the PS2P Probe is connected to the PS2 Stimulator.
Catalog Number
-
Brand Name
Integra®
Version/Model Number
PS2P
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"
Yes
For Single-Use
-
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
IPF
Product Code Name
Stimulator, muscle, powered
Public Device Record Key
fb06b1c6-a704-44c5-88b5-b4122d640b6a
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
August 08, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 197 |