OSSEODOC Control Unit + Pump 1600331-001

GUDID J00716003310011

Bien-Air Surgery SA

Surgical power tool system control unit, line-powered

• Primary Device ID: J00716003310011
• NIH Device Record Key: ad269f0c-7422-499b-9628-ca40ef2d7331
• Commercial Distribution Discontinuation: 2023-02-09
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: OSSEODOC Control Unit + Pump
• Version Model Number: 1600331
• Catalog Number: 1600331-001
• 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: false
• 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	J00716003310011 [Primary]

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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-02-10
• Device Publish Date: 2019-01-07

On-Brand Devices [OSSEODOC Control Unit + Pump]

• J00716003310011: 1600331
• 17630055505115: 1600331