IMAGE1 S CONNECT

GUDID 04048551422625

IMAGE1 S CONNECT II

Karl Storz GmbH & Co. KG

Camera control unit

• Primary Device ID: 04048551422625
• NIH Device Record Key: d5616fd1-abfd-4ac9-900f-b517a94853dc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IMAGE1 S CONNECT
• Version Model Number: TC201US
• Company DUNS: 315731430
• Company Name: Karl Storz GmbH & Co. KG
• 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	04048551422625 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162880

FDA Product Code

• GWG: Endoscope, neurological

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-03-10
• Device Publish Date: 2020-03-02

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