EndoRotor® EndoSurgery System - Console

Basic Information

• Brand Name: EndoRotor® EndoSurgery System - Console
• Primary DI: 00854172008216
• Version / Model: ESS-CONSOLE
• Catalog Number: ESS-CONSOLE
• Company Name: INTERSCOPE, INC
• Labeler DUNS: 968227913
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-04-06
• Public Version: 1
• Public Version Date: 2021-04-14
• Public Version Status: New
• Public Device Record Key: cbb079bf-d1d3-4ffc-b339-c62d2e9745bc

Device Description

EndoRotor® EndoSurgery System - Console

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: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PTE	Endoscopic Morcellator Gastroenterology	Obstetrics/Gynecology	884.1690	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46730	Tissue morcellation system control unit	A mains electricity (AC-powered) component of a tissue morcellation system used to power and regulate the system's handpiece blade via cable connection; some designs may also provide suction intended for removal of resected tissue. This device will typically have hand and/or foot controls.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00854172008216	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]