Handle for sinuscopy

GUDID 04059082014227

SOPRO-COMEG GmbH

Endoscope sheath, reusable

• Primary Device ID: 04059082014227
• NIH Device Record Key: 7f171e8c-010e-4c5a-8b55-c3c7256b733d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Handle for sinuscopy
• Version Model Number: 391 410 000
• Company DUNS: 507185952
• Company Name: SOPRO-COMEG GmbH
• Device Count: 1
• DM Exempt: false
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04059082014227 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K944656

FDA Product Code

• EOB: NASOPHARYNGOSCOPE (FLEXIBLE OR RIGID)

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[04059082014227]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-03-11
• Device Publish Date: 2016-09-12

On-Brand Devices [Handle for sinuscopy]

• 04059082029610: 191 270 001
• 04059082029603: 191 270 000
• 04059082014227: 391 410 000
• 04059082006321: 191 270 001BC
• 04059082006307: 191 270 000BC