EndoWrist

Basic Information

• Brand Name: EndoWrist
• Primary DI: 00886874113806
• Version / Model: 470545
• Company Name: INTUITIVE SURGICAL, INC.
• Labeler DUNS: 938647021
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-11-02
• Public Version: 24
• Public Version Date: 2023-08-25
• Public Version Status: Update
• Public Device Record Key: 266442e9-1836-4693-a12a-6cdf668141a7

Device Description

CURVED TIP STAPLER 45

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: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NAY	System,surgical,computer controlled instrument	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
63114	Robotic surgical cutting stapler, reusable	An electrically-powered surgical instrument intended to be used in conjunction with a robotic surgical system during a robotic endoscopic procedure for the expeditious transection and resection of tissues and the creation of anastomoses. The device is intended to mechanically cut the tissue and simultaneously apply surgical staples to the resulting sides of the cut line, with power from a motor. It is designed as a long shaft with a distal stapling mechanism designed to accept an endpiece/loading unit. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00886874113806	GS1