BenTips Piezosurgery Unit

GUDID D966BPS1LED0

BenTips Piezosurgery Control Unit

BENNETT JACOBY, DDS, MS, INC.

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• Primary Device ID: D966BPS1LED0
• NIH Device Record Key: 52a6d109-4ee6-4b62-a025-5451fa0affce
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BenTips Piezosurgery Unit
• Version Model Number: BPS1LED
• Company DUNS: 031283428
• Company Name: BENNETT JACOBY, DDS, MS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: false
• Serial Number: true
• 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
HIBCC	D966BPS1LED0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111290

FDA Product Code

• DZI: Drill, Bone, Powered

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-04-09
• Device Publish Date: 2021-04-01

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