Bur PM2-MIS P160 steel Ø4.0 St 1100680-001

GUDID 17630055512106

Bien-Air Surgery SA

Diamond ENT bur, single-use

• Primary Device ID: 17630055512106
• NIH Device Record Key: 5f6ec4a5-b8eb-4b2b-9f9e-ee78ece0e36c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bur PM2-MIS P160 steel Ø4.0 St
• Version Model Number: 1100680
• Catalog Number: 1100680-001
• Company DUNS: 481597719
• Company Name: Bien-Air Surgery SA
• Device Count: 1
• DM Exempt: true
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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	17630055512106 [Primary]

FDA Product Code

• EQJ: Bur, Ear, Nose And Throat

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-03-31
• Device Publish Date: 2025-03-21

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