đź“‹ FDA Reference
Dispo Fibrin Pipet TIPS B4182-2
American Scientific Products
Summary: The dispo fibrin pipet tips B4182-2 are specialized pipet tips used in clinical settings for handling fibrin-related substances. They are primarily used by laboratory technicians and clinicians in settings involving portal vein procedures.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K820532 ↗
Decision Date ?
April 8, 1982
Product Code ?
GIE
Device Class ?
Class 2
Evidence ?
0 studies
The dispo fibrin pipet tips B4182-2 were cleared through the FDA 510(k) pathway on April 8, 1982. Manufactured by American Scientific Products, this device is classified as a Class 2 medical device under product code GIE.
What It Is
The dispo fibrin pipet tips B4182-2 are designed for precise handling and transfer of fibrin or fibrinogen solutions in laboratory and clinical settings. These pipet tips ensure accurate measurement and minimal contamination, which is crucial in procedures involving blood coagulation and fibrin application. Their design is tailored to fit standard laboratory pipettes, making them versatile and easy to integrate into existing workflows.
FDA-Cleared Indications
- Use as a disposable pipette tip for handling or transferring fibrin-related materials, according to the manufacturer's labeling.
- Use with a compatible pipette or dispensing system in the laboratory or clinical setting.
Clinical Applications
- Transfer or dispense fibrin or fibrinogen solutions during laboratory preparation.
- Handle coagulation-related samples or materials when a disposable pipette tip is specified.
- Support preparation of fibrin-related materials in a controlled laboratory or clinical workflow.
Practical Considerations
- Confirm compatibility with the specific pipette or dispensing instrument before use.
- Use the labeled tip size and technique needed for the volume and viscosity of the material.
- Maintain aseptic or contamination-controlled technique when handling clinical or biologic materials.
- The available FDA record does not establish MRI safety; the tip should be kept outside the MRI environment unless its materials and use have been specifically assessed.
- This is a single-use disposable component; follow the manufacturer's instructions for disposal and do not reuse unless the labeling expressly permits it.
Frequently Asked Questions
What is dispo fibrin pipet tips b4182-2 used for?
They are used for handling and transferring fibrin solutions in clinical and laboratory settings, particularly in procedures involving the portal vein.
What specialties typically use this device?
Specialties such as hematology, vascular surgery, and liver surgery commonly use these pipet tips.
What are the FDA-cleared indications?
The device is indicated for use in procedures involving the portal vein, particularly those requiring precise fibrin handling.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.