Carefusion TT1615 - Temno Biopsy Device, 16G x 15cm, 5/CS
The CareFusion TT1615 Temno Biopsy Device is a precision-engineered medical instrument designed for soft tissue biopsy procedures with minimal patient discomfort. Featuring a high-quality stainless steel needle, this device ensures optimal sample retrieval while maintaining structural stability. Its ergonomic design enhances control, allowing for precise and secure tissue sample extraction. The device is sterilized for single-use applications, reducing contamination risks and ensuring compliance with medical safety standards.
This 16G x 15cm Temno Biopsy Device is widely used in interventional radiology, oncology, and pathology for obtaining high-quality tissue samples essential for disease diagnosis and treatment planning.
| Manufacturer Part Number | Manufacturer Name | Gauge Size | Biopsy Needle Size | Biopsy Needle With Introducer Cat. No. | Introducer Needle Size |
| TT1615 | Carefusion | 16G | 16 G x 15 cm | CTT1615 | 15 G x 10 cm |
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 |
Key Benefits
- Precision Sampling The sharp cutting edge ensures clean and intact core biopsy samples, improving diagnostic accuracy.
- Coaxial Design Enables multiple sample collections with a single puncture, minimizing tissue trauma and improving procedural efficiency.
- Minimized Patient Discomfort Designed for smooth penetration with minimal trauma, ensuring a better patient experience.
- Sterile, Single-Use Design Reduces the risk of cross-contamination and infection, ensuring adherence to healthcare safety protocols.
- Versatile Clinical Application Suitable for soft tissue biopsies across various anatomical regions.
Compatibility and Applications
The CareFusion TT1615 Temno Biopsy Device is compatible with standard biopsy procedures and imaging guidance techniques such as ultrasound, CT, and MRI. It is commonly used in hospitals, outpatient clinics, and diagnostic laboratories for obtaining high-quality tissue samples.
Common application scenarios include:
- Oncology Facilitates the diagnosis of malignancies through precise tissue sample analysis.
- Pathology Provides high-quality biopsy specimens for microscopic examination.
- Interventional Radiology Utilized in image-guided procedures for precision sampling.
- Gastroenterology and Hepatology Supports liver and soft tissue biopsies.
Usage Guidelines
To ensure optimal performance and safety, follow these best practices:
- Inspect the sterile packaging before use to confirm it is intact and undamaged.
- Utilize proper imaging techniques for guided needle insertion to enhance accuracy.
- Follow institutional biopsy protocols for patient positioning and procedural setup.
- Dispose of the needle safely after single use, adhering to medical waste disposal regulations.
- Refer to the manufacturers guidelines included with the product for detailed instructions.
Certifications, Safety Standards, and Regulatory Approvals
The CareFusion TT1615 Temno Biopsy Device meets stringent regulatory requirements, ensuring compliance with global medical safety standards:- FDA Approved Certified for medical use in the United States, ensuring adherence to strict quality and safety regulations.
- CE Marked Meets European health, safety, and environmental protection requirements.
- ISO 13485 Certified Manufactured following international quality management standards for medical devices.
Comparison with Competitor Products
Compared to similar biopsy devices on the market, the CareFusion TT1615 Temno Biopsy Device offers superior sample integrity and enhanced procedural efficiency. Unlike traditional biopsy needles, its coaxial design allows for multiple sample retrievals with a single puncture, minimizing patient discomfort while improving procedural accuracy. The sterile single-use design also reduces contamination risks, making it a preferred choice among healthcare professionals.Typical User Profile and Application Scenarios
The CareFusion TT1615 Temno Biopsy Device is primarily used by:- Oncologists For diagnosing tumors and other malignancies.
- Radiologists Performing image-guided biopsy procedures.
- Pathologists Processing soft tissue samples for laboratory analysis.
- General Surgeons Conducting biopsies in outpatient and inpatient settings.
Best Practices for Use and Maintenance
- Store in a dry, temperature-controlled environment to maintain sterility.
- Ensure proper handling with sterile gloves to prevent contamination.
- Use an appropriate disposal container for safe needle disposal after use.
- Train healthcare staff on proper biopsy techniques to optimize patient outcomes.
Regulatory and Safety Information
This product complies with global safety and regulatory standards to ensure medical reliability. Users should refer to their facilitys guidelines for biopsy procedures and follow appropriate infection control protocols.How to Order
To purchase the CareFusion TT1615 Temno Biopsy Device, add the product to your cart and proceed to checkout. For bulk orders or additional inquiries, contact CIA Medical customer service at (312) 275-5850 or submit a request via the contact form on this page.
