DEVICE: Nuvis (08538160080010)
Device Identifier (DI) Information
Nuvis
140-4010-1
Not in Commercial Distribution
140-4010-1
INTEGRATED ENDOSCOPY, INC.
140-4010-1
Not in Commercial Distribution
140-4010-1
INTEGRATED ENDOSCOPY, INC.
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 140mm 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 140mm. The Arthroscope is supplied sterile and is for single-use only. It is not intended to be re-used or re-sterilized.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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34856 | Rigid optical arthroscope, reusable |
An endoscope with a rigid inserted portion intended for the visual examination and treatment of the interior of a joint (e.g., knee, shoulder, elbow). It is inserted into the body through an artificial orifice created by an incision made during arthroscopy. Anatomical images are transmitted to the user through relayed lens optics or a fibreoptic bundle. This device is typically used to examine structural damage to a joint, often from sports injuries. The arthroscope eyepiece is normally interfaced with a video camera. This is a reusable device.
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FDA Product Code
[?]Product Code | Product Code Name |
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HRX | Arthroscope |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K140903 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Handling Environment Humidity: between 10 and 90 Percent (%) Relative Humidity |
Handling Environment Temperature: between 10 and 90 Degrees Celsius |
Storage Environment Humidity: between 10 and 95 Percent (%) Relative Humidity |
Storage Environment Temperature: between -30 and 60 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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Angle: 30 degree |
Outer Diameter: 4 Millimeter |
Length: 140 Millimeter |
Device Record Status
dd9aa198-9fbb-45dd-a4b7-173829935e59
November 17, 2023
6
February 08, 2018
November 17, 2023
6
February 08, 2018
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
08538160080027 | 10 | 08538160080010 | 2019-12-31 | Not in Commercial Distribution | Box |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
17149552400
tom@pinnaclemedtech.com
tom@pinnaclemedtech.com