OTIS-C-PLUS & OTIS-F EVO9069430

GUDID 03760154008112

Drill guide for use with OTIS-C-PLUS and OTIS-F osteosynthesis plates for HTO.

S.B.M

Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable

• Primary Device ID: 03760154008112
• NIH Device Record Key: f0e4d599-b76a-42f9-9f62-8aa9113bbb4d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OTIS-C-PLUS & OTIS-F
• Version Model Number: Drill guide
• Catalog Number: EVO9069430
• Company DUNS: 772462123
• Company Name: S.B.M
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Outer Diameter: 4.5 Millimeter
• Outer Diameter: 4.5 Millimeter
• Outer Diameter: 4.5 Millimeter
• Outer Diameter: 4.5 Millimeter
• Outer Diameter: 4.5 Millimeter
• Outer Diameter: 4.5 Millimeter
• Outer Diameter: 4.5 Millimeter
• Outer Diameter: 4.5 Millimeter
• Outer Diameter: 4.5 Millimeter
• Outer Diameter: 4.5 Millimeter
• Outer Diameter: 4.5 Millimeter
• Outer Diameter: 4.5 Millimeter
• Outer Diameter: 4.5 Millimeter
• Outer Diameter: 4.5 Millimeter
• Outer Diameter: 4.5 Millimeter
• Outer Diameter: 4.5 Millimeter
• Outer Diameter: 4.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	03760154008112 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[03760154008112]

Moist Heat or Steam Sterilization

[03760154008112]

Moist Heat or Steam Sterilization

[03760154008112]

Moist Heat or Steam Sterilization

[03760154008112]

Moist Heat or Steam Sterilization

[03760154008112]

Moist Heat or Steam Sterilization

[03760154008112]

Moist Heat or Steam Sterilization

[03760154008112]

Moist Heat or Steam Sterilization

[03760154008112]

Moist Heat or Steam Sterilization

[03760154008112]

Moist Heat or Steam Sterilization

[03760154008112]

Moist Heat or Steam Sterilization

[03760154008112]

Moist Heat or Steam Sterilization

[03760154008112]

Moist Heat or Steam Sterilization

[03760154008112]

Moist Heat or Steam Sterilization

[03760154008112]

Moist Heat or Steam Sterilization

[03760154008112]

Moist Heat or Steam Sterilization

[03760154008112]

Moist Heat or Steam Sterilization

[03760154008112]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-12-28
• Device Publish Date: 2023-12-20

Devices Manufactured by S.B.M

• 03760304681080 - SBM: 2024-07-03 Complete instrumentation tray composed of reusable surgical instruments for extremity surgery.
• 03760304681318 - SBM: 2024-07-03 250 x 250 sterilization basket lid
• 03760304681325 - SBM: 2024-07-03 250 x 250 sterilization basket with silicone mat
• 03760154001069 - OTIS-C-PLUS: 2024-06-28 Depth gauge for HTO.
• 03760154005685 - LIGAFIX: 2024-06-28 Chondral pick for ACL reconstruction.
• 03760154008167 - OTIS-F: 2024-06-28 Handle for the OTIS-F AO drill guide
• 03760154008174 - OTIS-F: 2024-06-28 AO drill guide
• 03760154008181 - OTIS-F: 2024-06-28 AO Ø 6.5 mm tap