Duns Number:127632602
Device Description: The NuVis™ Arthroscope is a non-deflectable rigid endoscopic optical instrument designed f 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.
Catalog Number
140-4010-1
Brand Name
Nuvis
Version/Model Number
140-4010-1
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 31, 2019
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K140903,K140903
Product Code
HRX
Product Code Name
Arthroscope
Public Device Record Key
dd9aa198-9fbb-45dd-a4b7-173829935e59
Public Version Date
March 31, 2020
Public Version Number
5
DI Record Publish Date
February 08, 2018
Package DI Number
08538160080027
Quantity per Package
10
Contains DI Package
08538160080010
Package Discontinue Date
December 31, 2019
Package Status
Not in Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |