Cook Medical G17627 - EXTRACTOR STONE NITINOL 3.0FR 115CM, EACH
NCircle Nitinol Tipless Stone Extractor
The NCircle Nitinol Tipless Stone Extractors are 3- or 4-wire nitinol baskets available in a range of French sizes, lengths, and basket diameters. Stone extraction with minimal trauma can be an arduous task, especially if you have to constantly adjust the field of vision or maneuver around a calyceal stone. The NCircle Nitinol Tipless Stone Extractor can help you resolve these challenges.
The NCircle Nitinol Tipless Stone Extractor is used for stone manipulation and removal in the urinary tract. The nitinol wire allows the basket to retain its shape even following extreme torsion. The unique tipless design allows you to open the basket at the base of the calyx and encircle the stone. Opening the basket at the base of the calyx reduces the likelihood of mucosal damage and perforation.
| Order Number | Reference Part Number | Fr | Length (cm) | Basket Diameter (cm) |
| G17627 | NTSE-030115-UDH | 3.0 | 115 | 1.0 |
Components
- Unidex handle
- Stone extractor
Tipless basket
The tipless configuration allows you to position the basket directly against the mucosal lining to minimize trauma, reduce bleeding, and maintain a clear working field.
Nitinol construction
The resilient, memory characteristics of the nitinol wire allow the basket to return to its original shape when the device is deployed.
Optimized control
The NCircle is designed to keep the stone and basket within the focal range of a ureteroscope.
Flexibility
The flexibility of the extractors outer sheath allows you to fully deflect the ureteroscope during stone manipulation.
Delta Wire Technology
The NCircle is available in a Delta Wire configuration. The Delta Wire design provides the largest wire mass possible when constructing a basket. The larger wire mass increases the radial force of the basket and allows for greater radial dilation. The 2.4 Fr flexible sheath permits continuous full deflection of the ureteroscope during stone manipulation, while improving irrigation flow.
Round wire
The basket of a typical helical stone extractor is constructed of round stainless steel wire. The sheath diameter determines how large the round wires can be. This illustration represents a cross section of a four-wire, round-wire basket in a sheath.
Delta Wire
This illustration represents a cross section of the four-wire, Delta Wire basket in a sheath and demonstrates the size and shape of the Delta Wire. The greater mass, combined with the inherent memory qualities of nitinol alloy, creates a unique basket with discernible proof of its increased radial force.
Intended Use
The NCircle Nitinol Tipless Stone Extractors are intended for stone manipulation and removal in the urinary tract.
Precautions
- These products are intended for use by physicians trained and experienced in urological procedures. Standard urological techniques should be employed.
- This device is conductive. Avoid contact with any electrified instrument.
- Enclose the device in the sheath before removing from the tray/holder.
- Do not use excessive force to manipulate this device. Damage to the device may occur.
Instructions for Use
- Remove the stone extractor from its outer package and move the thumb lever on the handle to the "Close" position to close the basket.
- Place the instrument insertion adapter (if included) securely into the endoscopic cap on the scope.
- With the insertion adapter in place, carefully insert the instrument into the scope.
- Under direct visualization, locate the stone and advance the extractor to a location just proximal to the stone. Slide the thumb lever on the handle to the Open position to deploy the basket near the stone and maneuver the device until the stone is within the basket.
- Once correctly positioned, draw the basket down around the stone and slide the thumb lever into the "Close" position.
- Maintaining position of the stone within the basket, retract the scope and basket.
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 |
How Supplied
Supplied sterile by ethylene oxide gas in peel-open packages. Intended for one-time use. Sterile if package is unopened or undamaged. Do not use product if there is doubt as to whether the product is sterile. Store in a dark, dry, cool place. Avoid extended exposure to light. Upon removal from the package, inspect the product to ensure no damage has occurred.
CAUTION: U.S. federal law restricts this device to sale by or on the order of a physician (or properly licensed practitioner).
