Accelus

GUDID B504OMCMP004140

Provision

Drilling power tool attachment, basic

• Primary Device ID: B504OMCMP004140
• NIH Device Record Key: b0e6f852-5928-4e8c-8d1b-efd490bdf68b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Accelus
• Version Model Number: CMP-00414
• 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	B504OMCMP004140 [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: 2024-05-30
• Device Publish Date: 2024-05-22

Devices Manufactured by Provision

• B504AEAR98310 - Arthrex: 2024-09-25
• B504GSA305225A80 - Allen Medical: 2024-09-25
• B504OM1305000 - CrossRoads: 2024-09-25
• B504OM1305280 - CrossRoads: 2024-09-25
• B504OM13090127YF10 - Zimmer: 2024-09-25
• B504OM150047010 - CrossRoads: 2024-09-25
• B504OM310680 - Synthes: 2024-09-25
• B504OM3190060 - Synthes: 2024-09-25