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Nuvis

FDA UDI

Class I (US FDA UDI)

by Integrated Endoscopy, Inc.

Identity

Trade Name
Nuvis FDA UDI
Generic Name
Arthroscopic access cannula, reusable FDA UDI
Device Name
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 single rotating stopcock. This single 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. FDA UDI
Model / Reference
IE58CAN-1 FDA UDI
Description
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 single rotating stopcock. This single 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. FDA UDI

Identifiers

Catalog Number
IE58CAN-1 FDA UDI
Primary DI / UDI-DI
00853816008025 FDA UDI
FDA Product Code
NBH FDA UDI
GMDN Term
Arthroscopic access cannula, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
888.1100 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size
Outer Diameter — 5.8 Millimeter FDA UDI

Category: Arthroscopic access cannula, reusable

Nuvis by Integrated Endoscopy, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Arthroscopic access cannula, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Integrated Endoscopy, Inc.

Sources (1)

  • FDA UDI 658707a9-9d66-4439-8892-2f25b71618ea 35 fields · synced Jun 8, 2026