Cook Medical G53564 - GUIDEWIRE, .038X145CM AMPL, AES-038145-DF, EACH
Amplatz Fixed Core Wire Guide
Amplatz wire guides are used to gain ureteral access, to establish a tract, and to assist in the placement, replacement and exchange of medical devices during urological procedures.
| Order Number | Reference Part Number | Diameter inch | Length (cm) | Tip Con guration | Coating |
| G53564 | AES-038145-DF | 0.038 | 145 | 5 cm double exible | PTFE |
Intended Use
Wire Guides are used to gain ureteral access, to establish a tract, and to assist in the placement, replacement, and exchange of medical devices during urological procedures. These wire guides are not intended for PTCA use.
Precautions
- When exchanging or withdrawing an instrument over the wire guide, secure and maintain the wire guide in place under fluoroscopy in order to avoid unexpected wire guide displacement.
- Manipulation of wire guide requires appropriate imaging control. Use caution not to force or over manipulate the wire guide when gaining access.
- When using wire guide through a metal cannula/needle, use caution as damage may occur to outer coating.
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 |
Instructions for Use
- Using aseptic technique, remove the wire from its outer packaging and place in the sterile field.
- Remove the wire guide from the holder.
- Advance the flexible end of the wire guide into the device and position to the desired anatomical location. NOTE: Endhole size and length of the device must be taken into consideration to ensure proper fit between wire guide and device.
- After wire guide use is complete, remove from patient and discard.
How Supplied
Supplied sterilized by ethylene oxide gas in peel-open packages. Intended for one-time use. Sterile if package is unopened or undamaged. Do not use the 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 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).
