ENDOPATH

Basic Information

• Brand Name: ENDOPATH
• Primary DI: 20705036012044
• Version / Model: 35LRT
• Catalog Number: 35LRT
• 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: 5
• Public Version Date: 2021-08-06
• Public Version Status: Update
• Public Device Record Key: f1781118-09a8-4471-a280-84503f2964e6
• 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: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

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

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
61425	Laparoscopic trocar blade, single-use	A rigid surgical instrument with a sharp pyramidal or conical point intended to puncture the abdominal wall to facilitate the introduction of a separate laparoscopic access cannula (not included) during laparoscopy. It is intended to fill the lumen of the laparoscopic access cannula, whereby following puncture it is withdrawn to provide a single-lumen access port to the abdominal cavity. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Direct Marking	10705036012047	GS1
Package	40705036012048	GS1	CASE	24	Not in Commercial Distribution	2021-08-05
Primary	20705036012044	GS1
Package	30705036012041	GS1	CASE	84	Not in Commercial Distribution	2021-08-05

Customer Contacts

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