Nuvis

Primary DI
00853816008018
Brand
Nuvis
Company
INTEGRATED ENDOSCOPY, INC.
Model
IE58CAN-2
Catalog number
IE58CAN-2
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 dual rotating stopcock. This dual 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.
Published
2020-03-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
NBHAccessories, Arthroscopic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NBHAccessories, ArthroscopicOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00853816008018PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00853816008018008538160080188538160080180853816008018

GMDN Terms#

Term, Definition table
TermDefinition
Arthroscopic access cannula, reusableA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter5.8Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
127632602
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08538160080010Nuvis140-4010-1140-4010-12018-02-08
00853816008001NuvisIE4030IE40302020-03-30
10853816008008NuvisIE4030-10IE4030-102020-03-30
00853816008025NuvisIE58CAN-1IE58CAN-12020-03-30
00853816008032NuvisIE58OBIE58OB2020-03-30
00853816008049NuvisIE58TRIE58TR2020-03-30
08538160080027Nuvis140-4010-1140-4010-12018-02-08

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