ENDOPATH

Basic Information

• Brand Name: ENDOPATH
• Primary DI: 20705036012150
• Version / Model: 511RT
• Catalog Number: 511RT
• Company Name: ETHICON ENDO-SURGERY, LLC
• Labeler DUNS: 044606982
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-07-15
• Public Version: 4
• Public Version Date: 2021-08-06
• Public Version Status: Update
• Public Device Record Key: cbadc024-733c-482a-9308-6d702f73c695
• Distribution End Date: 2021-08-05

Device Description

Endopath Reusable Trocar Stability Sleeve for the Endopath Resposable System

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: 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: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: ["Moist Heat or Steam Sterilization", "Hydrogen Peroxide"]

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
37148	Laparoscopic access cannula, reusable	A single-lumen surgical device intended to be percutaneously inserted through the abdominal wall to create an access port for a laparoscope/laparoscopic instrument during laparoscopy. The cannula is often provided with a shut-off valve for gas/fluid supply, and other sealing devices (e.g., dedicated seals/rings, caps, valves), to prevent insufflation gas leakage whilst allowing entry of instruments. It may include a sharp or blunt trocar blade to assist introduction and/or puncture the abdominal wall; if the trocar is included it may be referred to as a trocar or trocar assembly. It is available in a variety of dimensions and/or designs. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Direct Marking	10705036012153	GS1
Package	30705036012157	GS1	CASE	84	Not in Commercial Distribution	2021-08-05
Primary	20705036012150	GS1
Package	40705036012154	GS1	CASE	24	Not in Commercial Distribution	2021-08-05

Customer Contacts

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