IMAGE1 H3-LINK

GUDID 04048551356517

CCU,MODULAR,H3-LINK,US

Karl Storz GmbH & Co. KG

Endoscopic video image processing unit

• Primary Device ID: 04048551356517
• NIH Device Record Key: ec53b54c-1740-4709-9721-1209ae690d81
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IMAGE1 H3-LINK
• Version Model Number: TC300US
• 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

Customer Support Contacts

• Phone: +14242188201
• Email: regulatory@karlstorz.com
• Phone: +14242188201
• Email: regulatory@karlstorz.com
• Phone: +14242188201
• Email: regulatory@karlstorz.com
• Phone: +14242188201
• Email: regulatory@karlstorz.com
• Phone: +14242188201
• Email: regulatory@karlstorz.com
• Phone: +14242188201
• Email: regulatory@karlstorz.com
• Phone: +14242188201
• Email: regulatory@karlstorz.com
• Phone: +14242188201
• Email: regulatory@karlstorz.com
• Phone: +14242188201
• Email: regulatory@karlstorz.com
• Phone: +14242188201
• Email: regulatory@karlstorz.com
• Phone: +14242188201
• Email: regulatory@karlstorz.com
• Phone: +14242188201
• Email: regulatory@karlstorz.com
• Phone: +14242188201
• Email: regulatory@karlstorz.com
• Phone: +14242188201
• Email: regulatory@karlstorz.com
• Phone: +14242188201
• Email: regulatory@karlstorz.com
• Phone: +14242188201
• Email: regulatory@karlstorz.com
• Phone: +14242188201
• Email: regulatory@karlstorz.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04048551356517 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131953

FDA Product Code

• FET: Endoscopic video imaging system/component, gastroenterology-urology

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-05-19
• Device Publish Date: 2016-09-23

Devices Manufactured by Karl Storz GmbH & Co. KG

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• 04048551107904 - n.a.: 2024-12-23 Guide Wire, Ø 0.9 mm, pkg. of 6
• 04048551360460 - n.a.: 2024-12-23 Nitinol Guide Wire Ø 1.1 mm, 38.5 cm
• 04048551360484 - n.a.: 2024-12-23 Nitinol Guide Wire Ø 2 mm, 38.5 cm
• 04048551364437 - n.a.: 2024-12-23 Guide Sleeve, short, 10.5 cm
• 04048551364444 - n.a.: 2024-12-23 Guide Sleeve, long, 14.5 cm
• 04048551415320 - n.a.: 2024-12-20 KARL STORZ AIDA
• 04048551054901 - n.a.: 2024-12-09 Bulb, inflation, for endoscope