OTIS-C-PLUS EVO90FA800

GUDID 03760154008150

Complete instrumentation set composed of reusable surgical instruments intended to be used for high tibial osteotomy.

S.B.M

General surgical procedure kit, non-medicated, reusable

• Primary Device ID: 03760154008150
• NIH Device Record Key: 618e4e28-5884-4100-9055-9dd7fd43b94c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OTIS-C-PLUS
• Version Model Number: OTIS-C-PLUS complete instrumentation set
• Catalog Number: EVO90FA800
• 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: false
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	03760154008150 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[03760154008150]

Moist Heat or Steam Sterilization

[03760154008150]

Moist Heat or Steam Sterilization

[03760154008150]

Moist Heat or Steam Sterilization

[03760154008150]

Moist Heat or Steam Sterilization

[03760154008150]

Moist Heat or Steam Sterilization

[03760154008150]

Moist Heat or Steam Sterilization

[03760154008150]

Moist Heat or Steam Sterilization

[03760154008150]

Moist Heat or Steam Sterilization

[03760154008150]

Moist Heat or Steam Sterilization

[03760154008150]

Moist Heat or Steam Sterilization

[03760154008150]

Moist Heat or Steam Sterilization

[03760154008150]

Moist Heat or Steam Sterilization

[03760154008150]

Moist Heat or Steam Sterilization

[03760154008150]

Moist Heat or Steam Sterilization

[03760154008150]

Moist Heat or Steam Sterilization

[03760154008150]

Moist Heat or Steam Sterilization

[03760154008150]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-06-20
• Device Publish Date: 2024-06-12

On-Brand Devices [OTIS-C-PLUS]

• 03760154001052: Screwdriver for use with OTIS-C-PLUS osteosynthesis plates and associated OTIS screws for HTO.
• 03760154001045: Drill bit for use with OTIS-C-PLUS osteosynthesis plates for HTO.
• 03760154001038: Drill bit for use with OTIS-C-PLUS osteosynthesis plates for HTO.
• 03760154001014: Drill guide for use with OTIS-C-PLUS osteosynthesis plates for HTO.
• 03760154006279: OTIS-C-PLUS cleaning and sterilization basket.
• 03760154006248: OTIS-C-PLUS® countersink bit
• 03760154006224: OTIS-C-PLUS Ø 3 mm drill bit for temporary screw
• 03760154008150: Complete instrumentation set composed of reusable surgical instruments intended to be used for h
• 03760154001069: Depth gauge for HTO.