Nuvis
The Nuvis® Arthroscope is a non-deflectable rigid endoscopic optical instrument designed for illumination and visualization of internal anatomy of a patient within the knee, shoulder, hip,…
The Nuvis® Arthroscope is a non-deflectable rigid endoscopic optical instrument designed for illumination and visualization of internal anatomy of a patient within the knee, shoulder, hip, wrist, temporal mandibular joint, ankle, elbow, and feet joints. Integrated Endoscopy’s NuVis Arthroscope has a 142mm working length, an outside diameter of 4mm, a field of view of 105°, and a direction of view of 30°. The Arthroscope is designed to be used with a cannula compatible with a 4mm x 30° arthroscope with a working length of 142mm. The Arthroscope is supplied sterile and is for single-use only. It is not intended to be re-used or re-sterilized. This is the 10-pack configuration.
Who Else Makes It
Concentrated in Shanghai (7), Jiangsu (6), Guangdong (5). 6 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Modern Medical Equipment Manufacturing Ltd. | Heng Li, Dongguan | Guangdong | Contract manufacturer | 26 |
| Dongguan BAO Kang Dian ZI KE JI Limited | Dongguan | Guangdong | Contract manufacturer | 24 |
| Sanmina | Kunshan | Jiangsu | Contract manufacturer | 15 |
| Peter’s Technology (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 9 |
| Jiangsu Shenli Medical Production Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 6 |
| PAN-International Precision Electronic Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 4 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Hangzhou Fushan Medical Appliance Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 44 |
| Arthrex (Shanghai) Co., Ltd. | Shanghai | Shanghai | Exporter | 38 |
| Goals Sterilization Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 26 |
Showing 12 of 21. All 21 manufacturers in China registered for Arthroscope
Record
| Listed by | Integrated Endoscopy, Inc., United States |
|---|---|
| FDA product code | HRX |
| Device type | Arthroscope |
| Device class | Class 2 |
| Regulation | 21 CFR 888.1100 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K191594 |
| Record published | 2020-03-30 |
| Record revised | 2023-11-17 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Handling environment humidity 15 to 90 % RH; Handling environment temperature 10 to 40 °C; Storage environment humidity 15 to 90 % RH; Storage environment temperature 10 to 50 °C |
| Packaging | Box of 10 |
| Sizes | Angle 30 °; outer diameter 4 mm; length 140 to 142 mm |
| Distribution end date | 2019-12-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IE4030-10 | Angle 30 ° | In distribution |
| IE4030 | Angle 30 ° | In distribution |
| 140-4010-1 | Angle 30 ° | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Surgical Direct | Surgical Direct, Inc. | 299 |
| Arthroscope | Karl Storz GmbH & Co. KG | 278 |
| Conmed/Linvatec | Provision | 265 |
| Arthroscope | Smith & Nephew, Inc. | 255 |
| Medline | Medline Industries, Inc. | 205 |
| Arthroscope | Sterilmed, Inc. | 184 |
| Sustainable Technologies | Provision | 150 |
| Medline Renewal | Medline Industries, Inc. | 123 |
| Stryker | Provision | 113 |
| Arthrex® | Arthrex, Inc. | 109 |
| Arthrex | Provision | 109 |
| Eberle | Eberle GmbH & Co. KG | 92 |
Showing 12 of 567. All products under Arthroscope
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K191594 | 2019-07-11 |
| K140903 | 2014-07-17 |
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.