Nuvis IE4030
GUDID 00853816008001
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.
INTEGRATED ENDOSCOPY, INC.
Rigid arthroscope, reusable| Primary Device ID | 00853816008001 |
| NIH Device Record Key | f6ea5756-3f4e-413a-93dd-bcfec5e40e0f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Nuvis |
| Version Model Number | IE4030 |
| Catalog Number | IE4030 |
| Company DUNS | 127632602 |
| Company Name | INTEGRATED ENDOSCOPY, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Device Dimensions
| Length | 142 Millimeter |
| Angle | 30 degree |
| Outer Diameter | 4 Millimeter |
| Length | 142 Millimeter |
| Angle | 30 degree |
| Outer Diameter | 4 Millimeter |
| Length | 142 Millimeter |
| Angle | 30 degree |
| Outer Diameter | 4 Millimeter |
| Length | 142 Millimeter |
| Angle | 30 degree |
| Outer Diameter | 4 Millimeter |
| Length | 142 Millimeter |
| Angle | 30 degree |
| Outer Diameter | 4 Millimeter |
| Length | 142 Millimeter |
| Angle | 30 degree |
| Outer Diameter | 4 Millimeter |
| Length | 142 Millimeter |
| Angle | 30 degree |
| Outer Diameter | 4 Millimeter |
| Length | 142 Millimeter |
| Angle | 30 degree |
| Outer Diameter | 4 Millimeter |
| Length | 142 Millimeter |
| Angle | 30 degree |
| Outer Diameter | 4 Millimeter |
| Length | 142 Millimeter |
| Angle | 30 degree |
| Outer Diameter | 4 Millimeter |
| Length | 142 Millimeter |
| Angle | 30 degree |
| Outer Diameter | 4 Millimeter |
| Length | 142 Millimeter |
| Angle | 30 degree |
| Outer Diameter | 4 Millimeter |
| Length | 142 Millimeter |
| Angle | 30 degree |
| Outer Diameter | 4 Millimeter |
| Length | 142 Millimeter |
| Angle | 30 degree |
| Outer Diameter | 4 Millimeter |
| Length | 142 Millimeter |
| Angle | 30 degree |
| Outer Diameter | 4 Millimeter |
| Length | 142 Millimeter |
| Angle | 30 degree |
| Outer Diameter | 4 Millimeter |
| Length | 142 Millimeter |
| Angle | 30 degree |
| Outer Diameter | 4 Millimeter |
| Length | 142 Millimeter |
Operating and Storage Conditions
| Storage Environment Temperature | Between 10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 50 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00853816008001 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K191594
FDA Product Code
| HRX | Arthroscope |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-04-07 |
| Device Publish Date | 2020-03-30 |
On-Brand Devices [Nuvis]
| 08538160080027 | The NuVis™ Arthroscope is a non-deflectable rigid endoscopic optical instrument designed for i |
| 10853816008008 | The Nuvis® Arthroscope is a non-deflectable rigid endoscopic optical instrument designed for il |
| 00853816008049 | The trocar is a solid stainless needle used with cannula to close or block up the cannula openin |
| 00853816008032 | The obturator is a solid stainless steel needle used with cannula to close or block up the cannu |
| 00853816008025 | The cannula is a stainless-steel tube with no taper at the end, through which the Nuvis® arthro |
| 00853816008018 | The cannula is a stainless-steel tube with no taper at the end, through which the Nuvis® arthro |
| 00853816008001 | The Nuvis® Arthroscope is a non-deflectable rigid endoscopic optical instrument designed for il |
Trademark Results [Nuvis]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NUVIS 87080649 not registered Live/Pending |
Hyundai Motor America 2016-06-22 |
 NUVIS 86197605 4605400 Live/Registered |
Solar City, Inc. 2014-02-19 |
 NUVIS 86071045 4886325 Live/Registered |
Integrated Endoscopy, Inc. 2013-09-20 |
 NUVIS 79150261 not registered Dead/Abandoned |
Koninklijke Philips nv 2014-06-06 |
 NUVIS 77712612 3695911 Dead/Cancelled |
HYUNDAI MOTOR AMERICA 2009-04-13 |
 NUVIS 77708674 3880743 Live/Registered |
Solar City, Inc. 2009-04-07 |
 NUVIS 77659901 not registered Dead/Abandoned |
Daean Chaemical Co., Ltd. 2009-01-30 |
 NUVIS 74706082 2089707 Dead/Cancelled |
NIKON CORPORATION 1995-07-26 |
 NUVIS 73064021 1058809 Dead/Expired |
TENNECO CHEMICALS, INC. 1975-09-24 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.