Nuvis IE58CAN-2

GUDID 00853816008018

The cannula is a stainless-steel tube with no taper at the end, through which the Nuvis® arthroscope can be inserted into the body during arthroscopic surgery. It must be rigid and strong enough to protect the arthroscope from bending, breaking, chipping and any other potential damage that could befall the arthroscope during normal use. It will be able to accommodate the 4mm diameter of the arthroscope, while still leaving enough room for fluid movement. It must be an adequate length to protect the tip, but not long enough to block its image. This cannula version is named as dual rotating stopcock. This dual stopcock version is leak proof when used with an arthroscope, obturator, or trocar. The cannula locking mechanism is modeled after the Stryker SpeedLock™, so as to keep it similar to what the customer is used to. The cannula 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.

INTEGRATED ENDOSCOPY, INC.

Arthroscopic access cannula, reusable

• Primary Device ID: 00853816008018
• NIH Device Record Key: 714da96b-054f-4415-a80c-84b7a121dbae
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nuvis
• Version Model Number: IE58CAN-2
• Catalog Number: IE58CAN-2
• Company DUNS: 127632602
• Company Name: INTEGRATED ENDOSCOPY, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Outer Diameter: 5.8 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00853816008018 [Primary]

FDA Product Code

• NBH: Accessories, Arthroscopic

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00853816008018]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-04-07
• Device Publish Date: 2020-03-30

On-Brand Devices [Nuvis]

• 08538160080027: The NuVis™ Arthroscope is a non-deflectable rigid endoscopic optical instrument designed for i
• 10853816008008: The Nuvis® Arthroscope is a non-deflectable rigid endoscopic optical instrument designed for il
• 00853816008049: The trocar is a solid stainless needle used with cannula to close or block up the cannula openin
• 00853816008032: The obturator is a solid stainless steel needle used with cannula to close or block up the cannu
• 00853816008025: The cannula is a stainless-steel tube with no taper at the end, through which the Nuvis® arthro
• 00853816008018: The cannula is a stainless-steel tube with no taper at the end, through which the Nuvis® arthro
• 00853816008001: The Nuvis® Arthroscope is a non-deflectable rigid endoscopic optical instrument designed for il