None

Basic Information

• Brand Name: None
• Primary DI: 00886874119846
• Version / Model: 490101
• Company Name: INTUITIVE SURGICAL, INC.
• Labeler DUNS: 938647021
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-09-05
• Public Version: 2
• Public Version Date: 2020-03-02
• Public Version Status: Update
• Public Device Record Key: 8c164ab7-4c71-466b-a42a-31daf969b5b5

Device Description

Vision Probe Adapter and Suction Adapter

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
EOQ	Bronchoscope (flexible or rigid)	Ear, Nose, Throat	874.4680	2

GMDN Terms

Code	Name	Definition	Implantable	Status
37412	Medical device cleaning jet handpiece	A hand-operated device designed to regulate and direct a narrow stream (a jet) of water and/or air for the initial cleaning of laboratory glassware, pipettes, syringes, certain endoscopes, cannulae, surgical instruments and other devices prior to disinfection/sterilization. It is usually in the form of a pistol with an activation trigger, and may be fitted with different nozzles or a variable nozzle. It is typically connected via tubing to a tap (faucet) and/or a pressurized air source. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30886874119847	GS1	CASE	9	In Commercial Distribution
Package	10886874119843	GS1	BOX	10	In Commercial Distribution
Primary	00886874119846	GS1