Carefusion ACT1811 - Temno Biopsy Needle 18 Gauge x 11 cm, Coaxial Core, Precision Cutting, Sterile, 5/CS
The Carefusion ACT1811 Temno Biopsy Needle is a high-precision, 18-gauge, 11 cm biopsy instrument engineered for optimal core tissue sampling. Designed with a sharp bevel tip and coaxial cutting system, this single-use needle ensures clean, reliable tissue acquisition across a range of diagnostic procedures.
The ACT1811 supports image-guided biopsies under ultrasound, CT, or fluoroscopy, offering exceptional control and tactile feedback. Its ergonomic design and consistent performance make it a preferred tool for radiologists and interventional specialists performing percutaneous soft tissue biopsies.
| Manufacturer Part Number | Manufacturer Name | Gauge Size | Biopsy needle size | Introducer needle size | Usable length |
| ACT1811 | Carefusion | 18G | 18G x 11 cm | 17G x 6 cm | 5 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:
Coaxial Temno Cutting Technology: Ensures precise and intact core tissue collection with minimal trauma.
Sharp Bevel Tip: Facilitates smooth penetration and improved targeting accuracy.
Sterile, Single-Use Design: Reduces risk of cross-contamination and ensures compliance with infection control protocols.
Ergonomic Hub: Enhances control, comfort, and handling during procedures.
Versatile for Multiple Anatomical Sites: Suitable for soft tissue, renal, liver, and breast biopsies.
Compatibility and Applications:
Compatible With:
Image guidance systems including ultrasound, CT, and fluoroscopy
Introducer cannulas and coaxial sheath systems
Applications Include:
Percutaneous soft tissue biopsies
Diagnostic sampling of liver, kidney, lung, breast, and lymph nodes
Interventional radiology and oncology diagnostics
Inpatient and outpatient procedural suites
Usage Guidelines:
Confirm needle integrity and packaging before use.
Use with appropriate imaging guidance for precise targeting.
Insert under sterile technique, following clinical biopsy protocol.
Deploy cutting mechanism only after proper lesion positioning.
Dispose of in a sharps container immediately after use.
Certifications, Safety Standards, and Regulatory Approvals:
FDA-cleared for diagnostic biopsy procedures
CE-marked for European conformity
Manufactured under ISO 13485 and ISO 14971 quality standards
Complies with hospital infection control and sharps safety guidelines
Sterilized using validated EtO sterilization process
These certifications support the ACT1811s reliability, precision, and clinical safety in biopsy procedures.
Comparison with Competitor Products:
The Carefusion ACT1811 Temno needle provides several advantages over competing biopsy needles:
Consistent core sample quality due to Temnos spring-loaded cutting mechanism
Greater physician control via ergonomic handle and smooth plunger actuation
Wider application range due to its compatibility with various tissue types and imaging methods
Trusted brand pedigree with Carefusions reputation for precision medical devices
Typical User Profile and Application Scenarios:
Typical users include:
Interventional radiologists
Oncologists and hepatologists
Breast care specialists
Diagnostic lab professionals
Ideal usage settings:
Hospitals and cancer centers
Radiology departments
Outpatient biopsy suites
Specialized clinics with imaging capability
Best Practices for Use and Maintenance:
Maintain strict aseptic technique during handling.
Ensure the targeted lesion is properly visualized under imaging before advancing the needle.
Align bevel appropriately for directional control during tissue capture.
Do not reuseimmediate disposal in a sharps container is required after the procedure.
Store at room temperature and avoid moisture or puncturing the packaging before use.
Regulatory and Safety Information:
The Carefusion ACT1811 needle meets stringent global regulations for single-use diagnostic biopsy devices. Its FDA and CE compliance, along with ISO quality manufacturing, ensure safety, sterility, and efficacy for clinical use.
How to Order:
To order the Carefusion ACT1811 Temno Biopsy Needle, simply add the item to your cart and proceed through the secure checkout on CIA Medicals platform.
For bulk orders or product inquiries, contact CIA Medical at (312) 275-5850 or submit your request through the contact form on this page. Our team is available to provide expert assistance tailored to your clinical needs.
