Nuvis

Basic Information

• Brand Name: Nuvis
• Primary DI: 00853816008049
• Version / Model: IE58TR
• Catalog Number: IE58TR
• Company Name: INTEGRATED ENDOSCOPY, INC.
• Labeler DUNS: 127632602
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-03-30
• Public Version: 1
• Public Version Date: 2020-04-07
• Public Version Status: New
• Public Device Record Key: 9da24251-3051-47c0-914c-614d697395e5

Device Description

The trocar is a solid stainless needle used with cannula to close or block up the cannula opening. The trocar is identical to the obturator except the distal end is sharp whose purpose is to be able to cut into muscle/tendon. The trocar will be sold as a reusable non-sterile device and distributed independently. Each instrument is cleaned then sterilized by steam autoclave per customer policy and procedure.

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: 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
NBH	Accessories, Arthroscopic	Orthopedic	888.1100	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62458	Arthroscopic access cannula, reusable	A single-lumen, surgical device intended to be percutaneously inserted into a joint to create an access port for an arthroscope/arthroscopic instrument during arthroscopy. The cannula is designed to facilitate the passage of surgical instruments while preventing the escape of irrigation fluid and typically includes an internal watertight seal, and a port for drainage of fluid. It is available in a variety of dimensions and/or designs and may include one or more obturator(s) to facilitate insertion. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00853816008049	GS1