InstruSafe By Summit Medical, an Innovia Medical Company
Menu

OEM Manufacturing Capabilities

OEM

Trays

Materials

Aluminum

  • Lightweight
  • Higher durability than plastic

    IN-8620_m

    IN-8620 Olympus® Endoeye® Laparoscope HD

  • Greater thermal conductive properties than other materials

Stainless Steel

  • Withstands high pH washing and disinfecting
  • Higher durability than other materials

Color Options

Color Anodization

  • Available on entire tray or individual base and cover with aluminum

Dimensions

  • Existing stock sheet metal is available in a variety of sizes
  • New sheet metal can be created for specific needs

Laser Plaque

Laser Engraved Plaque

Labeling/Marking

  • Custom labeling
  • Part number
  • Branding and logo artwork
  • Available in digital or screen printed
  • IFU/Product Supplement
    • Created to match instrument validations with existing tray 510(k)s

      Plaque with Insturment Layout

      Plaque with Insturment Layout

  • Anodized Logos/Branding
    • Available with aluminum sheet metal
  • Screen Printing
    • Available on both aluminum and stainless steel sheet metal
  • Pad Printing
    • Available on both aluminum and stainless steel sheet metal
  • Laser Engraving
    • Available on anodized aluminum
  • Laser Annealing
    • Available on stainless steel

Internal Components

  • Customized ComponentsOEM Holder Examples
    • Design components to optimize layout and design
    • New molds specific for instrumentation
    • Water jet cut blanks specific for instrumentation
    • Molded holders made to specification
  • Standard Components
    • Over 200 pre-designed parts
    • Dividers, posts, small parts organizers
    • Medical Grade Silicone (blue or black colors available)
    • Water jet cut silicone holders for increased utilization

Packaging

  • Custom foam inserts for maximum protection during shipping
  • Box labeling can be created with company logo, branding and technical specifications
  • Individual or bulk packaging options

Engineering + Regulatory

Pic_4_OM-1006-AE_OEM_s

Example of a 3D model

Quality

  • Sterilization validation and feasibility testing coordination
  • FDA 510(k) clearances
  • FDA Registered
  • ISO 13485:2003 and NF EN ISO 13485:2012 Certified
  • CE Certificate
  • Early Release Prototypes
  • Production equivalent assemblies for review, testing, and fit verification

Documentation

  • SOLIDWORKS 3D modeling + rendering
  • Technical drawings
  • Tray Designs

InstruSafe OEM Products

Get Exactly What You Need. Customizable Trays for Every Instrument.

Summit Medical, an Innovia Medical Company, is a medical device manufacturer located in St. Paul, Minn. The company was founded in 1982 with the mission of developing, manufacturing and marketing products for microsurgery. Learn More