HS-Handpiece,angled,95mm,80k 1601107-001

GUDID 17630055506402

Bien-Air Surgery SA

Drilling power tool attachment, basic

• Primary Device ID: 17630055506402
• NIH Device Record Key: b1d9b229-88e1-4250-8a08-97b2fb33a624
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HS-Handpiece,angled,95mm,80k
• Version Model Number: 362682
• Catalog Number: 1601107-001
• 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	07630055506405 [Primary]
GS1	17630055506402 [Package]; Contains: 07630055506405; Package: [1 Units]; In Commercial Distribution

FDA Product Code

• NLY: Microdebrider, Ent, High Speed, Single Use, Reprocessed

Sterilization

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

[17630055506402]

Moist Heat or Steam Sterilization

[17630055506402]

Moist Heat or Steam Sterilization

[17630055506402]

Moist Heat or Steam Sterilization

[17630055506402]

Moist Heat or Steam Sterilization

[17630055506402]

Moist Heat or Steam Sterilization

[17630055506402]

Moist Heat or Steam Sterilization

[17630055506402]

Moist Heat or Steam Sterilization

[17630055506402]

Moist Heat or Steam Sterilization

[17630055506402]

Moist Heat or Steam Sterilization

[17630055506402]

Moist Heat or Steam Sterilization

[17630055506402]

Moist Heat or Steam Sterilization

[17630055506402]

Moist Heat or Steam Sterilization

[17630055506402]

Moist Heat or Steam Sterilization

[17630055506402]

Moist Heat or Steam Sterilization

[17630055506402]

Moist Heat or Steam Sterilization

[17630055506402]

Moist Heat or Steam Sterilization

[17630055506402]

Moist Heat or Steam Sterilization

[17630055506402]

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

• 17630055513752 - Bur PM2-150 80K Steel Ø4.0 St: 2024-12-12
• 17630055513769 - Bur PM2-150 80K Steel Ø3.1 St: 2024-12-12
• 17630055513783 - Bur PM2 80K Steel TD Ø1.1x5 St: 2024-12-12
• 17630055513790 - Bur PM2 80K Steel TD Ø1.1x4 St: 2024-12-12
• 17630055513813 - Bur Cranial Straight 25 mm St: 2024-12-12
• 17630055513820 - Bur Cranial Spiral 25mm St: 2024-12-12
• 17630055513837 - Bur Cranial Spiral 10mm St: 2024-12-12
• 17630055513844 - Bur Cranial Straight 10mm St: 2024-12-12