Urethrotomy sheath

GUDID 04059082029757

SOPRO-COMEG GmbH

Endoscope sheath, reusable

• Primary Device ID: 04059082029757
• NIH Device Record Key: 2e4016d9-5834-46df-8c71-0b1646af3d64
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Urethrotomy sheath
• Version Model Number: 195 110 050
• 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: true
• 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	04059082029757 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K971881

FDA Product Code

• EZO: Urethrotome

Sterilization

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

[04059082029757]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-03-11
• Device Publish Date: 2018-03-20

On-Brand Devices [Urethrotomy sheath]

• 04059082029870: 199 110 080
• 04059082029856: 199 110 050
• 04059082029818: 195 810 102
• 04059082029757: 195 110 050
• 04059082010991: 199 110 080BC
• 04059082010960: 199 110 050BC
• 04059082009803: 195 810 102BC
• 04059082009285: 195 110 050BC