Nuvis

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…

Registry build 21.09.26

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.

14manufacturers in China registered for this device type
4catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (5), Guangdong (3), Shandong (2). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code NBH
Manufacturer City Province Registered as Device types
Apex (Guangzhou) Tools & Orthopedics Company Guangzhou Guangdong Contract manufacturer 62
Shandong Weigao Orthopaedic Device Co., Ltd. Weihai Shandong Contract manufacturer 42
Suzhou Elite Precision Machinery Co., Ltd. Kunshan Jiangsu Contract manufacturer 35
B-ONE Medical (Suzhou) Co., Ltd. Suzhou Jiangsu Contract manufacturer 23
Suzhou Ahno Medical Devices Co., Ltd. Suzhou Jiangsu Contract manufacturer 17
Medtronic (Changzhou) Medical Devices Technology Co., Ltd. Changzhou Jiangsu Manufacturer 53
Arthrex (Shanghai) Co., Ltd. Shanghai Shanghai Exporter 38
Zhongshan Saxin Electric Heating Technology Co., Ltd. Zhongshan Guangdong Manufacturer 27
Anhui Shiyin Photoelectric Instrument Co., Ltd. Suzhou Anhui Specification developer 18
Suzhou Endophix Co., Ltd. Suzhou Jiangsu Manufacturer 17
Tianck Medical Co., Ltd. Huizhou Guangdong Manufacturer 10
Anqing Changfan Medical Instrument Co., Ltd. Anqing Anhui Manufacturer 9

Showing 12 of 14. All 14 manufacturers in China registered for Accessories, Arthroscopic

Record

Regulatory record for Nuvis
Listed by Integrated Endoscopy, Inc., United States
FDA product code NBH
Device type Accessories, Arthroscopic
Device class Class 1
Regulation 21 CFR 888.1100
Establishment Specification developer, Complaint-file establishment, Manufacturer
Premarket notification Exempt
Record published 2020-03-30

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Prescription Prescription only
Label carries lot or batch number
Sizes Outer diameter 5.8 mm

Catalogue Numbers

Catalogue numbers for Nuvis
Catalogue number Size Status
IE58CAN-1 Outer Diameter 5.8 mm In distribution
IE58TR In distribution
IE58CAN-2 Outer Diameter 5.8 mm In distribution
IE58OB In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Arthrex® Arthrex, Inc. 1,020
Accessories, Arthroscopic Smith & Nephew, Inc. 913
Millennium Avalign Technologies, Inc. 335
Surgical Direct Surgical Direct, Inc. 312
AED National Advanced Endoscopy Devices, Inc. 266
Elmed Elmed, Inc. 262
Acufex Smith & Nephew, Inc. 260
Razek Equipamentos Razek Equipamentos Ltda 235
Sports Med Instruments Medacta International SA 175
Conmed ConMed Corporation 159
Accessories, Arthroscopic Richard Wolf Gmbh 153
Vertebris Richard Wolf Gmbh 135

Showing 12 of 598. All products under Accessories, Arthroscopic

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer