HS Dia.Burr,coarse,Ø3.5x70,50k 1100554-001

GUDID 17630055506952

Bien-Air Surgery SA

Diamond ENT bur, reusable

• Primary Device ID: 17630055506952
• NIH Device Record Key: a881a067-423c-495b-abb1-005d48049307
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HS Dia.Burr,coarse,Ø3.5x70,50k
• Version Model Number: 340335
• Catalog Number: 1100554-001
• Company DUNS: 481597719
• Company Name: Bien-Air Surgery SA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• Serial Number: false
• 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	07630055506955 [Primary]
GS1	17630055506952 [Package]; Contains: 07630055506955; Package: [1 Units]; In Commercial Distribution

FDA Product Code

• EQJ: Bur, Ear, Nose And Throat

Sterilization

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

[17630055506952]

Moist Heat or Steam Sterilization

[17630055506952]

Moist Heat or Steam Sterilization

[17630055506952]

Moist Heat or Steam Sterilization

[17630055506952]

Moist Heat or Steam Sterilization

[17630055506952]

Moist Heat or Steam Sterilization

[17630055506952]

Moist Heat or Steam Sterilization

[17630055506952]

Moist Heat or Steam Sterilization

[17630055506952]

Moist Heat or Steam Sterilization

[17630055506952]

Moist Heat or Steam Sterilization

[17630055506952]

Moist Heat or Steam Sterilization

[17630055506952]

Moist Heat or Steam Sterilization

[17630055506952]

Moist Heat or Steam Sterilization

[17630055506952]

Moist Heat or Steam Sterilization

[17630055506952]

Moist Heat or Steam Sterilization

[17630055506952]

Moist Heat or Steam Sterilization

[17630055506952]

Moist Heat or Steam Sterilization

[17630055506952]

Moist Heat or Steam Sterilization

[17630055506952]

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

• 07630055508072 - PM2-S MIS: 2025-03-31
• 17630055508093 - PM2-Nose MIS D150: 2025-03-31
• 17630055512601 - PM2-Nose MIS P160: 2025-03-31
• 17630055506266 - Bur PM2-MIS D150 steel Ø2.0 St: 2025-03-31
• 17630055506273 - Bur PM2-MIS D150 steel Ø3.0 St: 2025-03-31
• 17630055506280 - Bur PM2-MIS D150 diam Ø2.0 St: 2025-03-31
• 17630055506297 - Bur PM2-MIS D150 diam Ø3.0 St: 2025-03-31
• 17630055506303 - Bur PM2-MIS D150 Mstick Ø1.8 St: 2025-03-31