RA XL Ø2.35x34 Zekrya 1100870-001

GUDID 17630055517156

Bien-Air Surgery SA

Steel dental bur, single-use

• Primary Device ID: 17630055517156
• NIH Device Record Key: bc4b86b9-42cf-4f97-8ffc-785e65d878cd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RA XL Ø2.35x34 Zekrya
• Version Model Number: 1100870
• Catalog Number: 1100870-001
• 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	17630055517156 [Primary]
GS1	17630055517637 [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

• 17630055519426 - Bur PM2-70 80K steel Ø1.5x80 St: 2026-02-23
• 17630055519433 - Bur PM2-125 80K steel Ø1.5 St: 2026-02-23
• 17630055519440 - Bur PM2-70 80K diam EC Ø2.5x80 St: 2026-02-23
• 17630055519457 - Bur PM2-70 80K diam EC Ø3.0x80 St: 2026-02-23
• 17630055519464 - Bur PM2-70 80K diam EC Ø3.5x80 St: 2026-02-23
• 17630055519471 - Bur PM2-70 80K diamC Ø1.0x80 St: 2026-02-23
• 17630055519488 - Bur PM2-70 80K FC Ø2.5 St: 2026-02-23
• 17630055519495 - Bur PM2-70 80K diamC Ø1.5x80 St: 2026-02-23