OTIS-C-PLUS EVO9069432

GUDID 03760154001038

Drill bit for use with OTIS-C-PLUS osteosynthesis plates for HTO.

S.B.M

Cannulated surgical drill bit, reusable Cannulated surgical drill bit, reusable Cannulated surgical drill bit, reusable Cannulated surgical drill bit, reusable Cannulated surgical drill bit, reusable Cannulated surgical drill bit, reusable Cannulated surgical drill bit, reusable Cannulated surgical drill bit, reusable Cannulated surgical drill bit, reusable Cannulated surgical drill bit, reusable Cannulated surgical drill bit, reusable Cannulated surgical drill bit, reusable Cannulated surgical drill bit, reusable Cannulated surgical drill bit, reusable Cannulated surgical drill bit, reusable Cannulated surgical drill bit, reusable Cannulated surgical drill bit, reusable

• Primary Device ID: 03760154001038
• NIH Device Record Key: cfd3208c-ef41-46e8-bd56-1558f873ecf6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OTIS-C-PLUS
• Version Model Number: Drill bit
• Catalog Number: EVO9069432
• 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
• Length: 195 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 195 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 195 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 195 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 195 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 195 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 195 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 195 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 195 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 195 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 195 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 195 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 195 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 195 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 195 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 195 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 195 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	03760154001038 [Primary]

FDA Product Code

• HTW: Bit, Drill

Sterilization

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

[03760154001038]

Moist Heat or Steam Sterilization

[03760154001038]

Moist Heat or Steam Sterilization

[03760154001038]

Moist Heat or Steam Sterilization

[03760154001038]

Moist Heat or Steam Sterilization

[03760154001038]

Moist Heat or Steam Sterilization

[03760154001038]

Moist Heat or Steam Sterilization

[03760154001038]

Moist Heat or Steam Sterilization

[03760154001038]

Moist Heat or Steam Sterilization

[03760154001038]

Moist Heat or Steam Sterilization

[03760154001038]

Moist Heat or Steam Sterilization

[03760154001038]

Moist Heat or Steam Sterilization

[03760154001038]

Moist Heat or Steam Sterilization

[03760154001038]

Moist Heat or Steam Sterilization

[03760154001038]

Moist Heat or Steam Sterilization

[03760154001038]

Moist Heat or Steam Sterilization

[03760154001038]

Moist Heat or Steam Sterilization

[03760154001038]

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