EndoWrist

Basic Information

• Brand Name: EndoWrist
• Primary DI: 00886874112151
• Version / Model: 470006
• Company Name: INTUITIVE SURGICAL, INC.
• Labeler DUNS: 938647021
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-07-08
• Public Version: 24
• Public Version Date: 2022-07-04
• Public Version Status: Update
• Public Device Record Key: aff1569f-b901-459d-91cc-e3e3d0cd8483

Device Description

LARGE NEEDLE DRIVER

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
64421	Robotic surgical needle holder, reusable	A surgical device intended to be used in conjunction with a robotic surgical system, to grasp a suture needle when pushing/pulling the needle and attached suture through tissue for suturing during a robotic endoscopic (e.g., laparoscopic) procedure. It has a long slender shaft with a distal forceps-like gripping mechanism and a proximal housing intended to be connected directly to an arm of the robotic surgical system. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00886874112151	GS1

Device Sizes

Type	Value	Unit	Text
Outer Diameter	8	Millimeter