ShBur 15°DCR Ø3.1mm St 1600577-003

GUDID 27630055505488

Bien-Air Surgery SA

ENT suction dissector

• Primary Device ID: 27630055505488
• NIH Device Record Key: 0e5a0415-f3b2-4d5a-9b89-e0694c88db95
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ShBur 15°DCR Ø3.1mm St
• Version Model Number: 1600577
• Catalog Number: 1600577-003
• 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	17630055505481 [Primary]
GS1	27630055505488 [Package]; Contains: 17630055505481; Package: Box [3 Units]; In Commercial Distribution

FDA Product Code

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

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: 2023-02-27
• Device Publish Date: 2023-02-17

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• 17630055519525 - Bur PM2-70 80K diam EC Ø4.0x80 St: 2026-02-24
• 27630055519539 - Bur PM2-70 80K steel Ø2.0 St: 2026-02-24
• 17630055519549 - Bur PM2-70 80K steel Ø2.0x80 St: 2026-02-24
• 17630055519556 - Bur PM2-70 80K diam Ø1.5 St: 2026-02-24
• 17630055519563 - Bur PM2-70 80K diam Ø1.5x80 St: 2026-02-24
• 17630055519570 - Bur PM2-70 80K diam EC Ø5.0x80 St: 2026-02-24
• 17630055519587 - Bur PM2-70 80K diamC Ø2.0 St: 2026-02-24