ShBlade 60°Concv Ø3.0mm DS St 1600573-005

GUDID 27630055505440

Bien-Air Surgery SA

ENT suction dissector

• Primary Device ID: 27630055505440
• NIH Device Record Key: 89a1e1da-d813-4723-b406-3b121cb11cc3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ShBlade 60°Concv Ø3.0mm DS St
• Version Model Number: 1600573
• Catalog Number: 1600573-005
• 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	17630055505443 [Primary]
GS1	27630055505440 [Package]; Contains: 17630055505443; Package: Box [5 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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• 17630055513790 - Bur PM2 80K Steel TD Ø1.1x4 St: 2024-12-12
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• 17630055513820 - Bur Cranial Spiral 25mm St: 2024-12-12
• 17630055513837 - Bur Cranial Spiral 10mm St: 2024-12-12
• 17630055513844 - Bur Cranial Straight 10mm St: 2024-12-12