invendo SPU Processing Unit

GUDID 04260444390075

invendo medical GmbH

Endoscopic control/video-imaging system

• Primary Device ID: 04260444390075
• NIH Device Record Key: 4b1af46c-59f2-4df0-aa13-f88226759cbc
• Commercial Distribution Discontinuation: 2019-06-18
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: invendo SPU Processing Unit
• Version Model Number: E210
• Company DUNS: 333191497
• Company Name: invendo medical 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: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260444390075 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173085

FDA Product Code

• FDF: Colonoscope And Accessories, Flexible/Rigid

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-06-19
• Device Publish Date: 2018-06-29

On-Brand Devices [invendo SPU Processing Unit]

• 04260444390075: E210
• 04260444390037: E200