Working element

GUDID 04059082030159

SOPRO-COMEG GmbH

Endoscope assembly adaptor

• Primary Device ID: 04059082030159
• NIH Device Record Key: 77ddc070-879f-4b94-97ea-9c75f0da1d34
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Working element
• Version Model Number: 196 010 010
• 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	04059082030159 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K945262

FDA Product Code

• FAJ: Cystoscope and accessories, flexible/rigid

Sterilization

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

[04059082030159]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-03-20

On-Brand Devices [Working element]

• 04059082030524: 198 010 020
• 04059082030517: 198 010 010
• 04059082030449: 196 800 000
• 04059082030166: 196 010 020
• 04059082030159: 196 010 010
• 04059082010458: 198 010 020BC
• 04059082010441: 198 010 010BC
• 04059082010311: 196 800 000BC
• 04059082009995: 196 010 020BC
• 04059082009964: 196 010 010BC