ENDOPATH TRISTAR

Basic Information

• Brand Name: ENDOPATH TRISTAR
• Primary DI: 20705036012181
• Version / Model: 512B
• Catalog Number: 512B
• 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: 4
• Public Version Date: 2021-06-08
• Public Version Status: Update
• Public Device Record Key: 79d3ad52-3fc2-4517-a061-f8f794891421
• Distribution End Date: 2020-11-02

Device Description

Endopath Tristar Blunt Tip Surgical Trocars with Radiolucent Sleeves

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
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 It is intended to fill the lumen of the laparoscopic access cannula, whereby following puncture it is withdrawn to provide a single-lumen access port to the abdominal cavity.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
Package	40705036012185	GS1	CASE	54	Not in Commercial Distribution	2020-11-02
Primary	20705036012181	GS1
Package	50705036012182	GS1	CASE	66	Not in Commercial Distribution	2020-11-02
Package	30705036012188	GS1	CASE	24	Not in Commercial Distribution	2020-11-02
Unit of Use	10705036012184	GS1

Customer Contacts

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