RA L Ø2.35x26 Zekrya 1100869-001

GUDID 17630055517149

Bien-Air Surgery SA

Steel dental bur, single-use

• Primary Device ID: 17630055517149
• NIH Device Record Key: ae4fb868-838f-4b99-a7d4-6441d24c4fec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RA L Ø2.35x26 Zekrya
• Version Model Number: 1100869
• Catalog Number: 1100869-001
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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	17630055517149 [Primary]
GS1	17630055517620 [Package]; Package: [3 Units]; In Commercial Distribution

FDA Product Code

• GFF: Bur, Surgical, General & Plastic Surgery

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: 2024-12-09
• Device Publish Date: 2024-11-29

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