Suction-irrigation-tube

GUDID 04059082006970

SOPRO-COMEG GmbH

Endoscope sheath, reusable

• Primary Device ID: 04059082006970
• NIH Device Record Key: 2fe9b8ab-d89b-4b5e-b954-f10f9ef50ce2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Suction-irrigation-tube
• Version Model Number: 191 400 110BC
• 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	04059082006970 [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

[04059082006970]

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 [Suction-irrigation-tube]

• 04059082029689: 191 400 110
• 04059082029672: 191 400 105
• 04059082029665: 191 400 100
• 04059082029634: 191 270 105
• 04059082029627: 191 270 100
• 04059082006970: 191 400 110BC
• 04059082006963: 191 400 105BC
• 04059082006956: 191 400 100BC
• 04059082006352: 191 270 105BC
• 04059082006338: 191 270 100BC