Cook Medical G14297 - SET, URETERAL DIALATOR, 5FRX 14FR, 076000, EACH
Ureteral Dilator Set
Used for dilation of the ureter prior to ureteroscopy and/or stone manipulation. AQ is a microthin layer of hydrophilic polymer that, when activated, attracts and holds water and other liquids to the dilator, creating a low-friction surface. This set includes dilators and a wire guide.
Polyethylene
| Order Number | Reference Part Number | Fr | Length cm |
| G14297 | 076000 | 6.0-18.0 | 60 |
Set Contains
- Nine radiopaque polyethylene dilators 60 cm long
- 0.038 inch (0.97 mm) diameter stainless steel wire guide 145 cm long with 3 cm flexible tip
NOTE: Prior to use, immerse AQ dilators in sterile water or isotonic saline to allow the hydrophilic surface to absorb water and become lubricious. This will ease placement under standard conditions.
CAUTION: Sterile if the package is unopened or undamaged. Do not use if package is broken.
CAUTION: Federal (U.S.A.) law restricts this device to sale by or on the order of a physician.
Contraindications
- There are no known contraindications.
Suggested Instructions for Using Ureteral Dilator Set
- Under x-ray or fluoroscopic control, cystoscopically pass the wire guide the desired distance into the ureter. (The safety index mark, 64 cm from the wire guides flexible tip, will be externally visible under normal circumstances.)
- Progressing from the smallest to the largest appropriate size, pass the radiopaque dilators over the wire guide while maintaining the wire guides position. NOTE: Dilators up to approximately 12.0 French may be passed through the working channel of the cystoscope. However, the telescope and inner scope elements must be removed - leaving the sheath - to accommodate the larger sizes.
CAUTION: Do not advance dilators beyond the 64 cm safety index mark. When the end of the dilator is at the mark, a 4 cm length of wire protrudes from the tip. Further advancement of the dilator will override the wire guide.
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 |
