Exactech

GUDID B504OM52178320

Provision

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• Primary Device ID: B504OM52178320
• NIH Device Record Key: bd9dd163-48fc-4d23-8623-7a8e9c1c2c6d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Exactech
• Version Model Number: 521-78-32
• 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	B504OM52178320 [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: 2024-05-27
• Device Publish Date: 2024-05-17

On-Brand Devices [Exactech]

• B504OM32115070: 321-15-07
• B504OM32115060: 321-15-06
• B504OM31535000: 315-35-00
• B504OM32152070: 321-52-07
• B504OM30111050: 301-11-05
• B504OM32152090: 321-52-09
• B504OM30111060: 301-11-06
• B504OM31901320: 319-01-32
• B504OM20178560: 201-78-56
• B504OM52178330: 521-78-33
• B504OM52178320: 521-78-32
• B504OM52178310: 521-78-31
• B504OM35190010: 351-90-01