GRAEFE Surgical Scalpel S33006-13

Overview

The GRAEFE Surgical Scalpel S33006-13 is a precision-engineered stainless steel anatomical scalpel designed for controlled, repeatable incisions in experimental surgical procedures, histological dissection, and preclinical research settings. Based on the classic GRAEFE profile—a design historically associated with ophthalmic and fine neurosurgical applications—this instrument features a straight, rigid blade with a 4 mm blade width and an overall length of 130 mm. Its geometry supports optimal tactile feedback and edge stability during delicate tissue separation, minimizing lateral deflection under moderate manual pressure. Constructed from high-carbon stainless steel (AISI 420 or equivalent), the blade undergoes precision grinding and passivation to ensure consistent sharpness, corrosion resistance, and biocompatibility per ISO 7153-1:2016 (Surgical instruments — Materials — Part 1: Stainless steels). The handle-integrated design eliminates detachable components, reducing contamination risk and simplifying sterilization workflows in GLP-compliant vivariums and academic surgery labs.

Key Features

• Monobloc construction: Seamless blade-and-shank design eliminates joints or welds, enhancing structural integrity and facilitating autoclave-compatible cleaning (134 °C, 3 bar, 5 min cycle).
• Optimized geometry: 4 mm blade width balances cutting efficiency with tissue displacement control—ideal for layered dissection of rodent brain, spinal cord, or ocular tissues.
• Surface finish: Electro-polished blade surface (Ra ≤ 0.2 µm) reduces protein adhesion and improves post-sterilization wettability, supporting consistent rinse validation per ISO 15883-1.
• Ergonomic shank profile: Tapered 130 mm shaft provides balanced torque distribution and minimizes hand fatigue during prolonged microdissection tasks.
• Traceable manufacturing: Each batch carries RWD’s internal lot code and conforms to ISO 13485:2016 quality management system requirements for Class I sterile medical devices.

Sample Compatibility & Compliance

This scalpel is intended for use with fresh, fixed, or cryosectioned biological specimens—including murine, porcine, and avian tissues—under standard biosafety level 2 (BSL-2) laboratory conditions. It is compatible with common fixation media (e.g., 4% paraformaldehyde, Bouin’s solution) and does not leach detectable nickel or chromium ions (< 0.1 ppm) when tested per ISO 10993-15 extraction protocols. The device meets the essential requirements of the EU Medical Device Regulation (MDR 2017/745) Annex I for non-invasive, non-sterile Class I devices. While supplied non-sterile, it is validated for terminal sterilization via saturated steam (EN 285), ethylene oxide (ISO 11135), or low-temperature hydrogen peroxide plasma (ISO 14937). Documentation includes material declarations compliant with REACH Annex XVII and RoHS Directive 2011/65/EU.

Software & Data Management

As a manually operated mechanical instrument, the S33006-13 requires no embedded electronics, firmware, or software integration. However, its use is fully traceable within digital lab notebooks (e.g., LabArchives, Benchling) and electronic quality management systems (eQMS). RWD provides a Certificate of Conformance (CoC) with each shipment, including batch number, manufacturing date, material certification (mill test report), and compliance statements aligned with FDA 21 CFR Part 820 and ISO 13485 audit trails. For institutions maintaining ALCOA+ data integrity standards, the CoC serves as a primary record linking instrument use to specific animal protocols (IACUC-approved) or histology SOPs.

Applications

• Preclinical neuroanatomy: Precise coronal or sagittal sectioning of rodent brains prior to Nissl staining or immunohistochemistry.
• Ocular surgery models: Corneal incision and lens capsule scoring in rabbit or porcine ex vivo eye perfusion studies.
• Cardiovascular dissection: Aortic arch isolation and adventitial layer removal in murine hypertension models.
• Tissue banking: Standardized trimming of biopsy specimens prior to OCT embedding or paraffin processing.
• Training modules: Hands-on surgical technique instruction in veterinary and biomedical graduate programs accredited by AVMA or EFOMP.

FAQ

Is the S33006-13 supplied sterile?

No. It is provided non-sterile and must be sterilized by the end user prior to first use, following institutional biosafety and SOP guidelines.
Can this scalpel be resterilized multiple times?

Yes. Validated for ≥50 cycles of steam sterilization without measurable degradation in edge hardness (tested per ASTM E384 Knoop microhardness) or surface pitting (per ISO 10555-1 visual inspection criteria).
Does RWD offer custom packaging or labeling for institutional procurement?

Yes. Custom barcoded blister packs, bulk cartons with Lot/Expiry labeling, and bilingual (EN/CN) IFUs are available upon formal purchase order with minimum order quantity (MOQ) of 500 units.
What is the recommended sharpening protocol if edge dulling occurs?

Sharpening is not recommended. The blade geometry and heat treatment are optimized for single-use-per-sterilization-cycle performance. Dull blades should be discarded per local biohazard waste regulations.
Is this product registered with the U.S. FDA?

Yes. Listed as a Class I exempt device (Product Code: FSY) under 21 CFR 878.4495, with FDA Establishment Registration Number: 3015900179.