Integra®

Basic Information

• Brand Name: Integra®
• Primary DI: 10381780037231
• Version / Model: PS2P
• Company Name: INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
• Labeler DUNS: 531408342
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-08
• Public Version: 3
• Public Version Date: 2023-01-20
• Public Version Status: Update
• Public Device Record Key: fb06b1c6-a704-44c5-88b5-b4122d640b6a

Device Description

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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Ethylene Oxide

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IPF	Stimulator, muscle, powered	Physical Medicine	890.5850	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47862	Abdominal/ENT/orthopaedic surgical probe, reusable	A slender, rod-like, hand-held manual surgical instrument intended to be used to explore cavities, wounds or fistulas during abdominal, ENT, and/or orthopaedic surgical interventions; it does not include stereotactic devices and is not dedicated to endoscopy. It may have a blunt bulbous, paddle-like, or pointed tip, may be single- or double-ended, and the shaft may be straight, bent or hooked. It is made of rigid or flexible metallic and/or synthetic polymer material. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Secondary	M272PS2P1	HIBCC
Primary	10381780037231	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Probe 17cm Length

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store in a cool, dry place