8404ZX

GUDID 04048551432778

C-MAC Monitor for CMOS Endoscopes

Karl Storz GmbH & Co. KG

Image display unit, colour

• Primary Device ID: 04048551432778
• NIH Device Record Key: a48a1d98-4915-4a17-8ddf-932ec0e4ba7e
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 8404ZX
• Catalog Number: 8404ZX
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04048551432778 [Primary]

FDA Product Code

• EOQ: Bronchoscope (flexible or rigid)

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: 2025-04-04
• Device Publish Date: 2025-03-27

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• 04048551012468 - NA: 2025-04-07 Irrigation Tube, for cleaning
• 04048551061343 - NA: 2025-04-07 15 Touch Screen
• 04048551067444 - NA: 2025-04-07 CO2 High Pressure Hose, American/Germ.
• 04048551069493 - NA: 2025-04-07 Mandrin, for 204808
• 04048551069530 - NA: 2025-04-07 Mandrin, for 204809