SBi

GUDID B504OM10030000

Provision

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• Primary Device ID: B504OM10030000
• NIH Device Record Key: 94a19f09-fd73-4774-ad69-47e4e4970de2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SBi
• Version Model Number: 100-3000
• Company DUNS: 016889401
• Company Name: Provision
• Device Count: 1
• DM Exempt: true
• 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: true
• 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
HIBCC	B504OM10030000 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-05-24
• Device Publish Date: 2024-05-16

On-Brand Devices [SBi]

• B504OM10030060: 100-3006
• B504OM10030040: 100-3004
• B504OM10030010: 100-3001
• B504OM10030000: 100-3000