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Bakes Common Bile Duct Malleable Surgical Dilators Set of 13 (1mm to 13mm) Set

  • Set Architecture: Complete turnkey instrumentation assembly comprising comprehensive surgical components.
  • Material Metallurgy: Handcrafted from certified ASTM F899 / AISI 410 & 420 surgical stainless steel.
  • Sterilization Tray: Modular layout compatible with standard hospital perforated autoclave trays and containers.
  • Thermal Endurance: Fully autoclavable at 134°C (273°F) for unlimited high-turnover reprocessing cycles.
  • Traceability & QA: Batch-controlled laser marking for asset management and hospital SPD tracking.
(Verfügbar)
OEM & International Cross-Reference Equivalents
UNIVERSAL NOMENCLATURE EU MDR 2017/745 & US FDA GUDID Classification
EMDN (EUDAMED): L0313
GENERAL SURGERY INSTRUMENTS, REUSABLE
GMDN Code: 47549
General surgical instrument, reusable
Manufacturer / Benchmark Catalog Number (REF) Specification Match
Medline PF121772 Exact Pattern Match

Notice of Nominative Fair Use: All manufacturer names, trademarks, symbols, and catalog part numbers are referenced solely for comparative identification, cross-reference, and equipment compatibility guidance. SurgiValley is an independent surgical manufacturer and is not affiliated with, sponsored by, or endorsed by any of the respective trademark owners.

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SKU: 090211126

Kategorien: Sets für die Allgemeinchirurgie

Tags: Bile Duct Dilators

Comprehensive Procedure Instrumentation Overview

The Bakes Common Bile Duct Malleable Surgical Dilators Set of 13 "(1mm to 13mm)" Set is a curated, comprehensive surgical instrumentation system engineered to satisfy the rigorous demands of institutional operating rooms, surgical centers, and clinical training programs. Every component within this system is individually balanced and calibrated for seamless procedural efficiency, eliminating surgical delays and standardizing tray management across sterile processing departments (SPD).

Tray Composition & Quality Assurance

System ParameterStandard Specification
System ClassificationSurgical Procedure Instrument Set
Component MetallurgyMedical-Grade AISI 410 / 420 Stainless Steel
Surface TreatmentElectropolished Anti-Glare Satin Finish
Autoclave Validation134°C (273°F) Pre-Vacuum Steam Cycle
Regulatory ComplianceISO 13485:2016 / CE MDR / FDA Registered

Surgical Instructions for Use & SPD Decontamination Protocol

  1. Disassembly & Pre-Cleaning: Open all ratchets, ring handles, and modular assemblies prior to ultrasonic immersion.
  2. Automated Washer-Disinfector: Process through standard thermal disinfection cycle (90°C–93°C for 5 minutes).
  3. Joint Lubrication: Apply non-silicone, water-soluble lubricant to box locks and articulating pins.
  4. Sterilization: Pack in validated sterilization wraps or rigid barrier containers. Autoclave at 134°C for 4 minutes with a 30-minute dry cycle.

Specifications


Set Bill of Materials & Included Instruments

#Component InstrumentQtyClinical Specification
1Bakes Common Duct Dilator 11 3/4″ Malleable Shaft 1mm Tip1Hospital grade surgical stainless steel, ISO 13485 & CE certified
2Bakes Common Duct Dilator 11 3/4″ Malleable Shaft 2mm Tip1Hospital grade surgical stainless steel, ISO 13485 & CE certified
3Bakes Common Duct Dilator 11 3/4″ Malleable Shaft 3mm Tip1Hospital grade surgical stainless steel, ISO 13485 & CE certified
4Bakes Common Duct Dilator 11 3/4″ Malleable Shaft 4mm Tip1Hospital grade surgical stainless steel, ISO 13485 & CE certified
5Bakes Common Duct Dilator 11 3/4″ Malleable Shaft 5mm Tip1Hospital grade surgical stainless steel, ISO 13485 & CE certified
6Bakes Common Duct Dilator 11 3/4″ Malleable Shaft 6mm Tip1Hospital grade surgical stainless steel, ISO 13485 & CE certified
7Bakes Common Duct Dilator 11 3/4″ Malleable Shaft 7mm Tip1Hospital grade surgical stainless steel, ISO 13485 & CE certified
8Bakes Common Duct Dilator 11 3/4″ Malleable Shaft 8mm Tip1Hospital grade surgical stainless steel, ISO 13485 & CE certified
9Bakes Common Duct Dilator 11 3/4″ Malleable Shaft 9mm Tip1Hospital grade surgical stainless steel, ISO 13485 & CE certified
10Bakes Common Duct Dilator 11 3/4″ Malleable Shaft 10mm Tip1Hospital grade surgical stainless steel, ISO 13485 & CE certified
11Bakes Common Duct Dilator 11 3/4″ Malleable Shaft 11mm Tip1Hospital grade surgical stainless steel, ISO 13485 & CE certified
12Bakes Common Duct Dilator 11 3/4″ Malleable Shaft 12mm Tip1Hospital grade surgical stainless steel, ISO 13485 & CE certified
13Bakes Common Duct Dilator 11 3/4″ Malleable Shaft 13mm Tip1Hospital grade surgical stainless steel, ISO 13485 & CE certified
Total Set Contents13 Pieces (13 Distinct Types)

Technical Specifications

Length (cm)33.02 cm
MaterialAISI 420 German Stainless Steel
Overall Length33.02 cm (13")

Specifications

Size Number13-Piece Set
Dimension13 Unique Instruments
Overall LengthTurnkey Operating Theater System
MaterialAISI 420 Martensitic German Stainless Steel / Autoclavable Storage Basket

What's Included in This Set

This set contains 13 instruments carefully selected for the procedure:

Size Number 13-Piece Set
Dimension 13 Unique Instruments
Overall Length Turnkey Operating Theater System
Material AISI 420 Martensitic German Stainless Steel / Autoclavable Storage Basket
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