Cook Medical G27012 - NEEDLE, TEMNO, ADJ, BIOPSY, 20G X 6CM, EACH
Quick-Core Biopsy Needle (10 mm Throw Length)
The Quick-Core is a lightweight biopsy needle with a beveled point stylet and an etched tip. The Set includes a coaxial needle which can be placed prior to the Quick-Core, allowing access to a target lesion to take multiple samples with only one puncture.
- The lightweight and compact Quick-Core Biopsy Needle facilitates one-handed operation during procedures.
- The precise, rapid-firing mechanism provides an intact core tissue sample.
- The beveled stylet permits easy penetration into the lesion with less trauma to surrounding tissues and organs.
- The etched tip enhances visualization under ultrasound.
| Order Number | Reference Part Number | Needle gage | Needle Length (cm) | Needle Throw Length (mm) |
| G27012 | QC-20-6.0-10T | 20 | 6 | 10 |
Intended Use
Quick-Core Biopsy Needles are intended for soft tissue biopsy. The product is intended for use by physicians trained and experienced in diagnostic and interventional techniques. Standard techniques for soft tissue biopsy should be employed.
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 |
Precautions
- When test firing Quick-Core Biopsy Needle, place distal beveled tip of inner stylet against solid surface before activating cutting cannula. This will prevent damage to cutting cannula tip.
- Lung puncture may result in an air embolus, which could lead to ischemia or infarction of major organs, including the brain or cardiac system.
- The potential effects of phthalates on pregnant/nursing women or children have not been fully characterized and there may be concern for reproductive and developmental effects.
Instructions for Use
- If using the coaxial needle, insert the coaxial needle to the border of the lesion.
- Prior to insertion, prepare the Quick-Core Biopsy Needle by pulling back on the plunger until a firm click is felt. This indicates that the needle spring is locked into ready position.
- With the stylet fully retracted, so that the specimen notch is completely covered by the cutting cannula, advance the needle to the area to be biopsied. Do not advance stylet until Quick-Core Biopsy Needle is in position.
- While maintaining needle position, advance stylet with thumb, to expose specimen notch within the area to be biopsied.
- Fire the cutting cannula by fully depressing the plunger with thumb to capture tissue within the specimen notch.
- Withdraw the needle from the biopsy area.
- To remove tissue specimen, pull back on the plunger until a firm click is felt. This indicates that the cutting cannula is locked into position. Push stylet forward to expose tissue specimen within the notch, and remove tissue.
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.
