OSSEODOC Control Unit 1600332-001

GUDID 17630055505122

Bien-Air Surgery SA

Surgical power tool system control unit, line-powered

• Primary Device ID: 17630055505122
• NIH Device Record Key: 9f9734c2-b995-43ad-9789-064bb3c2f775
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OSSEODOC Control Unit
• Version Model Number: 1600332
• Catalog Number: 1600332-001
• Company DUNS: 481597719
• Company Name: Bien-Air Surgery SA
• 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
GS1	17630055505122 [Primary]
HIBCC	J00716003320011 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K792159

FDA Product Code

• ERL: Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece

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: 2023-02-17
• Device Publish Date: 2023-02-09

On-Brand Devices [OSSEODOC Control Unit]

• J00716003320011: 1600332
• 17630055505122: 1600332