AccessGUDID - DEVICE: Nuvis (10853816008008)

GUDID

Device Identifier (DI) Information

Brand Name: Nuvis
Version or Model: IE4030-10
Commercial Distribution Status: In Commercial Distribution
Catalog Number: IE4030-10
Company Name: INTEGRATED ENDOSCOPY, INC.

Primary DI Number: 10853816008008
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 127632602 *Terms of Use

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HRX	Arthroscope

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K191594	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Humidity: between 15 and 90 Percent (%) Relative Humidity
Handling Environment Temperature: between 10 and 40 Degrees Celsius
Storage Environment Humidity: between 15 and 90 Percent (%) Relative Humidity
Storage Environment Temperature: between 10 and 50 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Angle: 30 degree
Outer Diameter: 4 Millimeter
Length: 142 Millimeter

Device Record Status

Public Device Record Key: 375fafe6-9486-410d-ac46-ae93f5c8a532
Public Version Date: November 17, 2023
Public Version Number: 2
DI Record Publish Date: March 30, 2020