OTIS-C-PLUS EVO9069436

GUDID 03760154001052

Screwdriver for use with OTIS-C-PLUS osteosynthesis plates and associated OTIS screws for HTO.

S.B.M

Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable

• Primary Device ID: 03760154001052
• NIH Device Record Key: 2bb349a8-e949-44fd-bf19-877c692e3f7e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OTIS-C-PLUS
• Version Model Number: Hexagonal screwdriver
• Catalog Number: EVO9069436
• 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: 3.5 Millimeter
• Outer Diameter: 3.5 Millimeter
• Outer Diameter: 3.5 Millimeter
• Outer Diameter: 3.5 Millimeter
• Outer Diameter: 3.5 Millimeter
• Outer Diameter: 3.5 Millimeter
• Outer Diameter: 3.5 Millimeter
• Outer Diameter: 3.5 Millimeter
• Outer Diameter: 3.5 Millimeter
• Outer Diameter: 3.5 Millimeter
• Outer Diameter: 3.5 Millimeter
• Outer Diameter: 3.5 Millimeter
• Outer Diameter: 3.5 Millimeter
• Outer Diameter: 3.5 Millimeter
• Outer Diameter: 3.5 Millimeter
• Outer Diameter: 3.5 Millimeter
• Outer Diameter: 3.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	03760154001052 [Primary]

FDA Product Code

• HXX: Screwdriver

Sterilization

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

[03760154001052]

Moist Heat or Steam Sterilization

[03760154001052]

Moist Heat or Steam Sterilization

[03760154001052]

Moist Heat or Steam Sterilization

[03760154001052]

Moist Heat or Steam Sterilization

[03760154001052]

Moist Heat or Steam Sterilization

[03760154001052]

Moist Heat or Steam Sterilization

[03760154001052]

Moist Heat or Steam Sterilization

[03760154001052]

Moist Heat or Steam Sterilization

[03760154001052]

Moist Heat or Steam Sterilization

[03760154001052]

Moist Heat or Steam Sterilization

[03760154001052]

Moist Heat or Steam Sterilization

[03760154001052]

Moist Heat or Steam Sterilization

[03760154001052]

Moist Heat or Steam Sterilization

[03760154001052]

Moist Heat or Steam Sterilization

[03760154001052]

Moist Heat or Steam Sterilization

[03760154001052]

Moist Heat or Steam Sterilization

[03760154001052]

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-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.