Novo Surgical Inc.

Basic Information

• Brand Name: Novo Surgical Inc.
• Primary DI: 00842331190070
• Version / Model: 9000-00053RM
• Catalog Number: 9000-00053RM
• Company Name: NOVO SURGICAL, INC.
• Labeler DUNS: 033029433
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-14
• Public Version: 2
• Public Version Date: 2024-01-19
• Public Version Status: Update
• Public Device Record Key: e16d54d2-e516-4d1d-b93e-8212546faa93
• Distribution End Date: 2024-01-18

Device Description

sheath, w/ cleaning channel, 5.0 mm diameter, 13" (33.0 cm), 3-piece modular system (reusable)

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: Yes
• 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
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62387	Flexible laparoscope protective guide	A rigid tubular device intended to be inserted through an in situ laparoscopic access cannula to function as a guiding and protective sheath for a flexible laparoscope, especially its distal end, as it is pushed through the access cannula and into the body. It is a metallic device typically made of stainless steel. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00842331190070	GS1

Customer Contacts

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