Deroyal D4511 - Safety Scalpel #11 50/CS
The Deroyal D4511 - Safety Scalpel #11 is a precision surgical instrument designed with a safety mechanism to protect healthcare professionals from accidental injuries during use. It features a #11 blade, which is a small, pointed, and sharp blade commonly used in procedures that require precise incisions. The safety scalpel is equipped with a retractable blade mechanism that enhances user safety by covering the blade when not in use.
Product Overview
The Deroyal D4511 Safety Scalpel combines the sharpness and precision of a #11 blade with a built-in safety mechanism to reduce the risk of accidental cuts. This scalpel is sterile, single-use, and designed for easy handling during delicate surgical procedures. The retractable blade ensures that the scalpel can be safely stored and disposed of after use without posing a danger to medical staff.
Product Characteristics
| Attribute | Details |
|---|---|
| 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" | Yes |
| 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 |
Design Features
- #11 Blade: The #11 blade is small, pointed, and extremely sharp, making it ideal for procedures requiring precision incisions, such as in dermatology, vascular surgery, and other delicate surgical tasks.
- Safety Retractable Mechanism: The scalpel features a retractable blade mechanism that allows the blade to be safely extended and retracted. This minimizes the risk of accidental cuts or injuries to healthcare professionals during handling and disposal.
- Sterile and Single-Use: Each scalpel is individually packaged in a sterile environment, ensuring it is ready for immediate use in surgery. The scalpel is designed for single-use, eliminating the need for cleaning or sterilization between uses.
- Ergonomic Handle: The scalpel handle is designed for comfort and control, providing surgeons with the ability to make precise cuts while minimizing hand fatigue during lengthy procedures.
- Color-Coded Safety Slider: The safety mechanism typically includes a color-coded slider, making it easy to identify when the blade is exposed or retracted.
Purpose and Use in Medical Settings
The Deroyal D4511 Safety Scalpel is primarily used in medical and surgical settings where fine, precise incisions are required. The #11 blade is well-suited for procedures that involve cutting delicate tissues or making small punctures. The safety mechanism is particularly beneficial in environments where sharp object injuries are a concern, such as operating rooms, emergency departments, and outpatient clinics.
Key Applications:
- Dermatological Procedures: The #11 blade is often used for skin incisions, biopsies, or the removal of small lesions and moles in dermatological surgeries.
- Vascular Surgery: The pointed blade is useful in making precise incisions for vascular surgeries, where accuracy is essential to avoid damaging blood vessels.
- General Surgery: The scalpel can be used in general surgical procedures where fine, controlled cuts are required, such as in laparoscopic surgeries or during the creation of surgical access points.
Certifications, Safety Standards, and Regulatory Approvals
- FDA Approval: The Deroyal D4511 Safety Scalpel meets FDA safety and efficacy standards for surgical instruments, ensuring it is safe for use in surgical procedures.
- ISO Standards: The scalpel complies with ISO standards for medical devices, ensuring high-quality manufacturing and safety in surgical environments.
- CE Marking: If distributed in Europe, the scalpel meets CE marking requirements, indicating compliance with health, safety, and environmental protection standards.
Comparison with Other Products
The Deroyal D4511 Safety Scalpel offers distinct advantages over traditional scalpels and other safety scalpel products:
- Safety Retractable Blade: Unlike traditional scalpels, which have a fixed blade, the Deroyal D4511 features a retractable blade mechanism, significantly reducing the risk of accidental injuries when passing or disposing of the scalpel.
- #11 Blade Precision: The fine, sharp point of the #11 blade makes this scalpel ideal for precise cutting tasks that require accuracy and control, providing better outcomes in delicate procedures compared to broader blades.
- Sterile and Ready to Use: Being pre-packaged in sterile conditions, the scalpel is ready for immediate use in surgery, eliminating the risk of contamination and the need for pre-procedure sterilization.
Common User Profile
- Surgeons and Surgical Assistants: Surgeons and their assistants use the scalpel during procedures requiring precise incisions, particularly in vascular, dermatological, and general surgeries.
- Emergency Room Physicians: In emergency settings, the scalpel can be used for procedures such as suturing or making incisions to drain abscesses.
- Dermatologists: The #11 blade is commonly used in dermatology for precise excisions or biopsies of skin tissue.
Typical Scenarios for Use
- Skin Lesion Removal: The sharp, pointed blade is ideal for removing skin lesions, such as moles or cysts, with minimal damage to surrounding tissues.
- Vascular Access Creation: The scalpel can be used to create precise incisions for the insertion of catheters or other vascular devices.
- Incisions in Laparoscopic Surgery: The fine blade is often used to create access incisions during minimally invasive laparoscopic procedures.
Best Practices for Using and Maintaining the Product
- Ensure Blade Retraction: Before handling the scalpel, ensure that the blade is in its retracted position to prevent accidental injuries. Only extend the blade when ready to use it in the procedure.
- Use with Sterile Technique: Always handle the scalpel using sterile gloves and in a sterile environment to prevent contamination during surgery.
- Single-Use Disposal: Dispose of the scalpel in an approved sharps container after use. The scalpel is designed for single use, and attempting to reuse it can compromise patient safety and increase the risk of infection.
How to Order
- Online Ordering: Add the Deroyal D4511 - Safety Scalpel #11 to your cart and proceed to checkout on the CIA Medical website.
- Customer Service: For bulk orders or inquiries, contact CIA Medical customer service at (312) 275-5850 or use the contact form available on this page.
Conclusion
The Deroyal D4511 - Safety Scalpel #11 is a high-precision surgical tool designed for use in procedures requiring delicate and accurate incisions. Its #11 blade is ideal for dermatological, vascular, and general surgeries, while the retractable safety mechanism enhances user safety by preventing accidental injuries during handling and disposal. The sterile, single-use design ensures patient safety and convenience, making it a reliable choice for healthcare professionals in various medical settings.
