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Nuvis

FDA UDI

Class II (US FDA UDI)

by Integrated Endoscopy, Inc.

Identity

Trade Name
Nuvis FDA UDI
Generic Name
Rigid optical arthroscope, reusable FDA UDI
Device Name
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. FDA UDI
Model / Reference
140-4010-1 FDA UDI
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 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. FDA UDI

Identifiers

Catalog Number
140-4010-1 FDA UDI
Primary DI / UDI-DI
08538160080010 FDA UDI
510(k) Number
K140903 FDA UDI
FDA Product Code
HRX FDA UDI
GMDN Term
Rigid optical arthroscope, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.1100 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Angle — 30 degree FDA UDI
Outer Diameter — 4 Millimeter FDA UDI
Length — 140 Millimeter FDA UDI

Nuvis by Integrated Endoscopy, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Integrated Endoscopy, Inc.

Sources (1)

  • FDA UDI dd9aa198-9fbb-45dd-a4b7-173829935e59 39 fields · synced Jun 8, 2026