OTIS EVO90FAH12

GUDID 03760154000901

Instrument for use with OTIS implants for HTO.

S.B.M

Surgical depth gauge, reusable Surgical depth gauge, reusable Surgical depth gauge, reusable Surgical depth gauge, reusable Surgical depth gauge, reusable Surgical depth gauge, reusable Surgical depth gauge, reusable Surgical depth gauge, reusable Surgical depth gauge, reusable Surgical depth gauge, reusable Surgical depth gauge, reusable Surgical depth gauge, reusable Surgical depth gauge, reusable Surgical depth gauge, reusable Surgical depth gauge, reusable Surgical depth gauge, reusable Surgical depth gauge, reusable

• Primary Device ID: 03760154000901
• NIH Device Record Key: 3710a67b-34d0-4181-a854-baad120ae8a2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OTIS
• Version Model Number: metallic trial implant
• Catalog Number: EVO90FAH12
• 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

• Height: 12 Millimeter
• Height: 12 Millimeter
• Height: 12 Millimeter
• Height: 12 Millimeter
• Height: 12 Millimeter
• Height: 12 Millimeter
• Height: 12 Millimeter
• Height: 12 Millimeter
• Height: 12 Millimeter
• Height: 12 Millimeter
• Height: 12 Millimeter
• Height: 12 Millimeter
• Height: 12 Millimeter
• Height: 12 Millimeter
• Height: 12 Millimeter
• Height: 12 Millimeter
• Height: 12 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	03760154000901 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[03760154000901]

Moist Heat or Steam Sterilization

[03760154000901]

Moist Heat or Steam Sterilization

[03760154000901]

Moist Heat or Steam Sterilization

[03760154000901]

Moist Heat or Steam Sterilization

[03760154000901]

Moist Heat or Steam Sterilization

[03760154000901]

Moist Heat or Steam Sterilization

[03760154000901]

Moist Heat or Steam Sterilization

[03760154000901]

Moist Heat or Steam Sterilization

[03760154000901]

Moist Heat or Steam Sterilization

[03760154000901]

Moist Heat or Steam Sterilization

[03760154000901]

Moist Heat or Steam Sterilization

[03760154000901]

Moist Heat or Steam Sterilization

[03760154000901]

Moist Heat or Steam Sterilization

[03760154000901]

Moist Heat or Steam Sterilization

[03760154000901]

Moist Heat or Steam Sterilization

[03760154000901]

Moist Heat or Steam Sterilization

[03760154000901]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-12-27
• Device Publish Date: 2023-12-19

On-Brand Devices [OTIS]

• 03760154001090: Impactor tip to be used with OTIS implants for HTO.
• 03760154001083: Impactor body to be used with OTIS implants for HTO.
• 03760154000932: Instrument for use with OTIS implants for HTO.
• 03760154000925: Instrument for use with OTIS implants for HTO.
• 03760154000918: Instrument for use with OTIS implants for HTO.
• 03760154000901: Instrument for use with OTIS implants for HTO.
• 03760154000895: Instrument for use with OTIS implants for HTO.
• 03760154000888: Instrument for use with OTIS implants for HTO.
• 03760154000871: Instrument for use with OTIS implants for HTO.
• 03760154000864: Instrument for use with OTIS implants for HTO.
• 03760154000857: Instrument for use with OTIS implants for HTO.
• 03760154000840: Instrument for use with OTIS implants for HTO.
• 03760154008129: Screwdriver for OTIS® screw extraction
• 03760154006262: Slotted hammer for OTIS metallic trial implants, to be used with OTIS implants for HTO.
• 03760154006255: Handle for OTIS metallic trial implants, to be used with OTIS implants for HTO.
• 03760304680809: OTIS cleaning and sterilization basket.