ENDOPATH

Basic Information

• Brand Name: ENDOPATH
• Primary DI: 20705036001864
• Version / Model: EPH03
• Catalog Number: EPH03
• Company Name: ETHICON ENDO-SURGERY, LLC
• Labeler DUNS: 044606982
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 6
• Record Status: Published
• Publish Date: 2016-07-15
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: d028893b-7c68-44d3-a57d-a4e64ed288a6
• Distribution End Date: 2016-09-30

Device Description

Endopath Electrosurgery Probe Plus II Pencil Foot Control Pencil Grip Handles with Suction and Irrrigation for Foot Control Monopolar Elctrosurgery Use only with Probe Plus II Shafts

Device Characteristics

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

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GCJ	Laparoscope, general & plastic surgery	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
56296	Open-surgery electrosurgical handpiece/electrode, bipolar, single-use	A sterile rigid combined electrosurgical handpiece and bipolar electrode, intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation during an open surgical procedure. It is available in a variety of forms (e.g., pen, pistol-shaped forceps, pincer-shaped forceps, scissors) and may also include irrigation, aspiration, lavage and/or surgical plume (smoke) evacuation features to support its primary electrosurgical function. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30705036001861	GS1	CASE	12	Not in Commercial Distribution	2016-09-30
Primary	20705036001864	GS1
Unit of Use	10705036001867	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -22 – 60 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 10 – 80 Percent (%) Relative Humidity