PM2-A125 1600769-001

GUDID J00716007690

Bien-Air Surgery SA

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• Primary Device ID: J00716007690
• NIH Device Record Key: fa955069-6a05-49bf-a885-0464861fcccc
• Commercial Distribution Discontinuation: 2023-02-09
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: PM2-A125
• Version Model Number: 1600769
• Catalog Number: 1600769-001
• 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	J00716007690 [Direct Marking]
HIBCC	J00716007690011 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173066

FDA Product Code

• HBE: Drills, Burrs, Trephines & Accessories (Simple, Powered)

Sterilization

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

[J00716007690]

Moist Heat or Steam Sterilization

[J00716007690]

Moist Heat or Steam Sterilization

[J00716007690]

Moist Heat or Steam Sterilization

[J00716007690]

Moist Heat or Steam Sterilization

[J00716007690]

Moist Heat or Steam Sterilization

[J00716007690]

Moist Heat or Steam Sterilization

[J00716007690]

Moist Heat or Steam Sterilization

[J00716007690]

Moist Heat or Steam Sterilization

[J00716007690]

Moist Heat or Steam Sterilization

[J00716007690]

Moist Heat or Steam Sterilization

[J00716007690]

Moist Heat or Steam Sterilization

[J00716007690]

Moist Heat or Steam Sterilization

[J00716007690]

Moist Heat or Steam Sterilization

[J00716007690]

Moist Heat or Steam Sterilization

[J00716007690]

Moist Heat or Steam Sterilization

[J00716007690]

Moist Heat or Steam Sterilization

[J00716007690]

Moist Heat or Steam Sterilization

[J00716007690]

Moist Heat or Steam Sterilization

[J00716007690]

Moist Heat or Steam Sterilization

[J00716007690]

Moist Heat or Steam Sterilization

[J00716007690]

Moist Heat or Steam Sterilization

[J00716007690]

Moist Heat or Steam Sterilization

[J00716007690]

Moist Heat or Steam Sterilization

[J00716007690]

Moist Heat or Steam Sterilization

[J00716007690]

Moist Heat or Steam Sterilization

[J00716007690]

Moist Heat or Steam Sterilization

[J00716007690]

Moist Heat or Steam Sterilization

[J00716007690]

Moist Heat or Steam Sterilization

[J00716007690]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2023-02-10
• Device Publish Date: 2019-01-07

On-Brand Devices [PM2-A125]

• J00716007690: 1600769
• 17630055505719: 1600769