invendoscope

GUDID 04260444390112

invendo medical GmbH

Flexible video colonoscope, single-use

• Primary Device ID: 04260444390112
• NIH Device Record Key: d236d47b-d79b-408f-98f6-932275e32b84
• Commercial Distribution Discontinuation: 2019-06-18
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: invendoscope
• Version Model Number: SC210
• 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: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• 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	04260444390112 [Primary]
GS1	04260444390129 [Package]; Package: [5 Units]; Discontinued: 2019-06-18; Not in Commercial Distribution

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: true

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 [invendoscope]

• 04260444390112: SC210
• 04260444390013: SC200