None

Basic Information

• Brand Name: None
• Primary DI: 00886874110096
• Version / Model: 370386
• Company Name: INTUITIVE SURGICAL, INC.
• Labeler DUNS: 938647021
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-25
• Public Version: 4
• Public Version Date: 2020-03-02
• Public Version Status: Update
• Public Device Record Key: a25fbd06-e519-4fb0-9e81-6f5a274f40d1
• Distribution End Date: 2016-10-11

Device Description

OBTURATOR, LATCHING, SHARP

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
35692	Rigid endoscope obturator	An endoscopic device that is a component of a rigid endoscope assembly that has a distally rounded, solid, head or end that is placed into the sheath of a rigid endoscope in order to fill out the sheath's lumen (open end), thereby assisting its insertion into the body and protecting against damage to the patient. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00886874110096	GS1

Device Sizes

Type	Value	Unit	Text
Outer Diameter	8	Millimeter