OTIS-F EVO9080000

GUDID 03760154009485

OTIS-F cleaning and sterilization basket.

S.B.M

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