Urethrotomy sheath

GUDID 04059082010991

SOPRO-COMEG GmbH

Endoscope sheath, reusable

• Primary Device ID: 04059082010991
• NIH Device Record Key: 98db12b3-b407-4a29-b235-928f7fe146dc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Urethrotomy sheath
• Version Model Number: 199 110 080BC
• 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	04059082010991 [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

[04059082010991]

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 [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