OTIS-F EVO9080000

GUDID 03760154009485

OTIS-F cleaning and sterilization basket.

S.B.M

Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable

• Primary Device ID: 03760154009485
• NIH Device Record Key: f2c0b860-b41d-4150-be73-5e9e117e0de4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OTIS-F
• Version Model Number: Cleaning and sterilization basket
• Catalog Number: EVO9080000
• 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	03760154009485 [Primary]

FDA Product Code

• FSM: Tray, Surgical, Instrument

Sterilization

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

[03760154009485]

Moist Heat or Steam Sterilization

[03760154009485]

Moist Heat or Steam Sterilization

[03760154009485]

Moist Heat or Steam Sterilization

[03760154009485]

Moist Heat or Steam Sterilization

[03760154009485]

Moist Heat or Steam Sterilization

[03760154009485]

Moist Heat or Steam Sterilization

[03760154009485]

Moist Heat or Steam Sterilization

[03760154009485]

Moist Heat or Steam Sterilization

[03760154009485]

Moist Heat or Steam Sterilization

[03760154009485]

Moist Heat or Steam Sterilization

[03760154009485]

Moist Heat or Steam Sterilization

[03760154009485]

Moist Heat or Steam Sterilization

[03760154009485]

Moist Heat or Steam Sterilization

[03760154009485]

Moist Heat or Steam Sterilization

[03760154009485]

Moist Heat or Steam Sterilization

[03760154009485]

Moist Heat or Steam Sterilization

[03760154009485]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-12-29
• Device Publish Date: 2023-12-21

On-Brand Devices [OTIS-F]

• 03760154009485: OTIS-F cleaning and sterilization basket.
• 03760154009492: Complete instrumentation tray composed of reusable surgical instruments intended to be used for
• 03760154008181: AO Ø 6.5 mm tap
• 03760154008174: AO drill guide
• 03760154008167: Handle for the OTIS-F AO drill guide