Carefusion TT1611 - Temno Biopsy Device 16G x 11cm, Sharp Bevel Tip, Blue Handle, Precision Soft Tissue Sampling, 5/BX

Carefusion TT1611 - Temno Biopsy Device 16G x 11cm, Sharp Bevel Tip, Blue Handle, Precision Soft Tissue Sampling, 5/BX

The Carefusion TT1611 Temno Biopsy Device is a precision-engineered, single-use soft tissue biopsy tool designed to deliver accurate and consistent core samples. With a 16-gauge diameter and an 11 cm length, this device features a sharp bevel tip and ergonomic blue handle, offering superior control and penetration in a variety of percutaneous biopsy procedures.

Temno biopsy devices are trusted in clinical environments for their reliability, clean core retrieval, and user-friendly operation. The compact design makes the TT1611 particularly suitable for ultrasound-guided procedures and tight access anatomical areas.

Device Characteristics

Key Benefits:

• Sharp Bevel Tip: Enhances tissue penetration with minimal trauma, allowing for high-quality sample acquisition.

• Consistent Core Retrieval: Optimized notch and cannula configuration provide intact and diagnostically reliable samples.

• Ergonomic Grip: Blue handle offers a secure and comfortable hold, supporting controlled deployment even in delicate procedures.

• Single-Use & Sterile: Reduces the risk of cross-contamination, ensuring safety and compliance with infection control standards.

• Ideal Size for Versatile Access: The 16G x 11cm size allows easy navigation in both superficial and moderately deep anatomical targets.

Compatibility and Applications:

• Applications Include:

  • Percutaneous biopsy of soft tissues (e.g., liver, lung, kidney, lymph nodes)

  • CT- or ultrasound-guided procedures

  • Diagnostic core sampling for histopathology

  • Interventional radiology and minimally invasive surgeries

• Compatible With:

  • Standard coaxial introducers or guiding sheaths

  • Imaging modalities (Ultrasound, CT)

  • Hospital and outpatient diagnostic settings

Usage Guidelines:

• Ensure all sterile protocols are followed before use.

• Under imaging guidance, position the device at the biopsy target.

• Activate the spring-loaded mechanism to capture the tissue sample.

• Remove and inspect the core, then repeat if additional samples are needed.

• Discard device safely after single use according to biomedical waste regulations.

• Refer to the included instructions for use (IFU) for detailed guidance.

Certifications, Safety Standards, and Regulatory Approvals:

• FDA-cleared and CE-marked for clinical use

• Manufactured under ISO 13485 quality system

• Sterilized using EtO (Ethylene Oxide)

• Latex-free, suitable for patients with sensitivities

• These certifications ensure high performance, safety, and global regulatory compliance in biopsy procedures.

  Comparison with Competitor Products:
  The Carefusion TT1611 Temno device stands out due to:

  • High sample integrity compared to standard aspiration or fine-needle biopsies

  • Sharper bevel tip that reduces insertion force and patient discomfort

  • Trusted brand reputation in biopsy and interventional solutions

  • User-focused design, offering a smoother biopsy experience for clinicians

  Its robust construction and consistent core results make it a top choice for diagnostic accuracy in pathology.

  Typical User Profile and Application Scenarios:
  Used by:

  • Interventional radiologists

  • Pathologists

  • Oncology and general surgeons

  • Diagnostic imaging professionals

  Application settings include:

  • Hospital operating rooms

  • Imaging-guided biopsy suites

  • Outpatient diagnostic centers

  • Cancer screening programs

  Best Practices for Use and Maintenance:

  • Always use under appropriate imaging guidance and physician supervision.

  • Avoid excessive force or off-angle insertions to maintain sample quality.

  • Keep device in original packaging until ready for use to ensure sterility.

  • Do not reuse; the device is designed strictly for single-use only.

  • Store in a cool, dry environment away from direct sunlight.

  Regulatory and Safety Information:
  The Temno TT1611 is classified as a Class II medical device, meeting FDA, CE, and ISO 13485 requirements. It supports biopsy procedures that align with standard protocols in pathology and oncology, contributing to accurate and timely diagnoses.

  How to Order:
  To purchase the Carefusion TT1611 Temno Biopsy Device, add it to your cart on CIA Medicals website and proceed through the secure checkout process.

  For bulk orders, clinical consultations, or product inquiries, contact CIA Medical at (312) 275-5850 or submit a message using the contact form on this page. Our team is ready to assist with all your procedural biopsy needs.