HS-Handpiece,straight,70mm,80k 1601104-001

GUDID 17630055506372

Bien-Air Surgery SA

Drilling power tool attachment, basic

• Primary Device ID: 17630055506372
• NIH Device Record Key: 6988a448-62e2-4ffb-9e47-38e69abdb3f4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HS-Handpiece,straight,70mm,80k
• Version Model Number: 362645
• Catalog Number: 1601104-001
• 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	07630055506375 [Primary]
GS1	17630055506372 [Package]; Contains: 07630055506375; Package: [1 Units]; In Commercial Distribution

FDA Product Code

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

Sterilization

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

[17630055506372]

Moist Heat or Steam Sterilization

[17630055506372]

Moist Heat or Steam Sterilization

[17630055506372]

Moist Heat or Steam Sterilization

[17630055506372]

Moist Heat or Steam Sterilization

[17630055506372]

Moist Heat or Steam Sterilization

[17630055506372]

Moist Heat or Steam Sterilization

[17630055506372]

Moist Heat or Steam Sterilization

[17630055506372]

Moist Heat or Steam Sterilization

[17630055506372]

Moist Heat or Steam Sterilization

[17630055506372]

Moist Heat or Steam Sterilization

[17630055506372]

Moist Heat or Steam Sterilization

[17630055506372]

Moist Heat or Steam Sterilization

[17630055506372]

Moist Heat or Steam Sterilization

[17630055506372]

Moist Heat or Steam Sterilization

[17630055506372]

Moist Heat or Steam Sterilization

[17630055506372]

Moist Heat or Steam Sterilization

[17630055506372]

Moist Heat or Steam Sterilization

[17630055506372]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-03-02
• Device Publish Date: 2023-02-22

Devices Manufactured by Bien-Air Surgery SA

• 27630055514626 - Bur PM2-70 80K diam C Ø2.3 St: 2024-04-09
• 27630055514732 - Bur PM2-70 80K diam C Ø3.1 St: 2024-04-09
• 17630055515756 - Bur PM2-70 80K diam Ø0.6 St: 2024-04-09
• 17630055515763 - Bur PM2-70 80K diam Ø0.8 St: 2024-04-09
• 27630055515777 - Bur PM2-70 80K diam Ø1.0 St: 2024-04-09
• 27630055515784 - Bur PM2-70 80K diam Ø1.4 St: 2024-04-09
• 27630055515791 - Bur PM2-70 80K diam Ø1.8 St: 2024-04-09
• 27630055515807 - Bur PM2-70 80K diam Ø2.3 St: 2024-04-09