None

Basic Information

• Brand Name: None
• Primary DI: 00886874111048
• Version / Model: 400180
• 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: 4
• Public Version Date: 2020-03-02
• Public Version Status: Update
• Public Device Record Key: 333e4c5f-c138-44d9-8bb3-80863a37356f

Device Description

TIP COVER ACCESSORY

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
NAY	System,surgical,computer controlled instrument	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36152	Electrosurgical system monitor/shield	A dedicated unit designed to interface with an electrosurgical system to help detect and manage high frequency leakage of current from active electrodes used in combination with endoscopes or other instruments during endoscopic procedures (especially laparoscopic).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10886874111045	GS1	BOX	10	In Commercial Distribution
Primary	00886874111048	GS1
Package	30886874111049	GS1	CASE	72	In Commercial Distribution

Device Sizes

Type	Value	Unit	Text
Outer Diameter	8	Millimeter