ShBlade 15°Concv Ø4.0mm DS St 1600570-005

GUDID 27630055505419

Bien-Air Surgery SA

ENT suction dissector

• Primary Device ID: 27630055505419
• NIH Device Record Key: 432c9547-b702-4d55-a28d-783af77bb1ba
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ShBlade 15°Concv Ø4.0mm DS St
• Version Model Number: 1600570
• Catalog Number: 1600570-005
• 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	17630055505412 [Primary]
GS1	27630055505419 [Package]; Contains: 17630055505412; 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

Devices Manufactured by Bien-Air Surgery SA

• 17630055513752 - Bur PM2-150 80K Steel Ø4.0 St: 2024-12-12
• 17630055513769 - Bur PM2-150 80K Steel Ø3.1 St: 2024-12-12
• 17630055513783 - Bur PM2 80K Steel TD Ø1.1x5 St: 2024-12-12
• 17630055513790 - Bur PM2 80K Steel TD Ø1.1x4 St: 2024-12-12
• 17630055513813 - Bur Cranial Straight 25 mm St: 2024-12-12
• 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