Nuvis
Basic Information
- Brand Name
- Nuvis
- Primary DI
- 00853816008025
- Version / Model
- IE58CAN-1
- Catalog Number
- IE58CAN-1
- Company Name
- INTEGRATED ENDOSCOPY, INC.
- Labeler DUNS
- 127632602
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-03-30
- Public Version
- 1
- Public Version Date
- 2020-04-07
- Public Version Status
- New
- Public Device Record Key
- 658707a9-9d66-4439-8892-2f25b71618ea
Device Description
The cannula is a stainless-steel tube with no taper at the end, through which the Nuvis® arthroscope can be inserted into the body during arthroscopic surgery. It must be rigid and strong enough to protect the arthroscope from bending, breaking, chipping and any other potential damage that could befall the arthroscope during normal use. It will be able to accommodate the 4mm diameter of the arthroscope, while still leaving enough room for fluid movement. It must be an adequate length to protect the tip, but not long enough to block its image. This cannula version is named as single rotating stopcock. This single stopcock version is leak proof when used with an arthroscope, obturator, or trocar. The cannula locking mechanism is modeled after the Stryker SpeedLock™, so as to keep it similar to what the customer is used to. The cannula will be sold as a reusable non-sterile device and distributed independently. Each instrument is cleaned then sterilized by steam autoclave per customer policy and procedure.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NBH | Accessories, Arthroscopic | Orthopedic | 888.1100 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62458 | Arthroscopic access cannula, reusable | A single-lumen, surgical device intended to be percutaneously inserted into a joint to create an access port for an arthroscope/arthroscopic instrument during arthroscopy. The cannula is designed to facilitate the passage of surgical instruments while preventing the escape of irrigation fluid and typically includes an internal watertight seal, and a port for drainage of fluid. It is available in a variety of dimensions and/or designs and may include one or more obturator(s) to facilitate insertion. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00853816008025 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 5.8 | Millimeter |