Cook Medical G34110 - SET, STENT, RESONANCE, RMS-060024-R, EACH
Resonance Metallic Ureteral Stent
Used for temporary stenting of the ureter in adult patients with extrinsic ureteral obstruction. Optimized compressive and radial strengths allow it to remain indwelling for up to 12 months, providing continuous renal drainage. The unique coil design allows urine to flow even in instances of extreme compression.
The Resonance Metallic Ureteral Stent Set contains (set components may vary):
- Resonance metal stent with pigtail straightener
- Radiopaque introduction catheter and sheath
- HiWire Nitinol Core wire guide (not included in the United States; optional component outside the United States)
| Order Number | Reference Part Number | MR Status | French Size | Length (cm) |
| G34110 | RMS-060024-R | MR Conditional | 6.0 | 24 |
A clear introducer system
Resonances stent positioner and clear sheath provide improved visualization and reference points for first and second pigtail deployment for all stent sizes.
A maximum indwelling time of 12 months
Resonance reduces the need for frequent stent changes and may thereby decrease the risk of infection.
MRI Conditional (up to 3 tesla)
Resonance has been demonstrated to pose no known hazard in a specified MRI environment with specified conditions of use.
WhyResonance Metallic Ureteral Stent?
The Resonance stent is specifically designed for extrinsic compression to mitigate many of the problems encountered with traditional plastic ureteral stents and other forms of treatment. The optimized compressive and radial strength of Resonance allows the stent to remain indwelling for up to 12 months. This long indwelling time reduces the need for frequent stent changes and may thereby decrease the risk of infection. The tightly wound metallic coil maintains its patency so that urine can drain continuously under severe extrinsic compression. Resonance is introduced coaxially through a sheath and removed using standard cystoscopic techniques.
Device Characteristics
| What MRI safety information does the labeling contain? | MR Conditional |
| 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
If the package is opened or damaged when received, do not use. Visually inspect with particular attention to kinks, bends and breaks. If an abnormality is detected that would prohibit proper working condition, do not use. Please notify Cook for return authorization. Do not use this device for any purpose other than the stated intended use. Store in a dark, dry location away from temperature extremes. Inventory rotation of sterile products is essential. Verify the expiration date on the package label prior to using the product. If the expiration date has lapsed, do not use or resterilize the device. If the product package is open or damaged when received, do not use this device.
