Flex-X / IMAGE 1 S

GUDID 04048551344385

Video Uretero-Renoscope FLEX-XC

Karl Storz GmbH & Co. KG

Flexible video ureterorenoscope, reusable

• Primary Device ID: 04048551344385
• NIH Device Record Key: 84e0cd01-b781-49fa-a0d9-fff3deea6460
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Flex-X / IMAGE 1 S
• Version Model Number: 11278VSU
• 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	04048551344385 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141250

FDA Product Code

• FGB: Ureteroscope and accessories, flexible/rigid

Sterilization

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

[04048551344385]

Liquid Chemical;Peracetic Acid;Ethylene Oxide;Hydrogen Peroxide

[04048551344385]

Liquid Chemical;Peracetic Acid;Ethylene Oxide;Hydrogen Peroxide

[04048551344385]

Liquid Chemical;Peracetic Acid;Ethylene Oxide;Hydrogen Peroxide

[04048551344385]

Liquid Chemical;Peracetic Acid;Ethylene Oxide;Hydrogen Peroxide

[04048551344385]

Liquid Chemical;Peracetic Acid;Ethylene Oxide;Hydrogen Peroxide

[04048551344385]

Liquid Chemical;Peracetic Acid;Ethylene Oxide;Hydrogen Peroxide

[04048551344385]

Liquid Chemical;Peracetic Acid;Ethylene Oxide;Hydrogen Peroxide

[04048551344385]

Liquid Chemical;Peracetic Acid;Ethylene Oxide;Hydrogen Peroxide

[04048551344385]

Liquid Chemical;Peracetic Acid;Ethylene Oxide;Hydrogen Peroxide

[04048551344385]

Liquid Chemical;Peracetic Acid;Ethylene Oxide;Hydrogen Peroxide

[04048551344385]

Liquid Chemical;Peracetic Acid;Ethylene Oxide;Hydrogen Peroxide

[04048551344385]

Liquid Chemical;Peracetic Acid;Ethylene Oxide;Hydrogen Peroxide

[04048551344385]

Liquid Chemical;Peracetic Acid;Ethylene Oxide;Hydrogen Peroxide

[04048551344385]

Liquid Chemical;Peracetic Acid;Ethylene Oxide;Hydrogen Peroxide

[04048551344385]

Liquid Chemical;Peracetic Acid;Ethylene Oxide;Hydrogen Peroxide

[04048551344385]

Liquid Chemical;Peracetic Acid;Ethylene Oxide;Hydrogen Peroxide

[04048551344385]

Liquid Chemical;Peracetic Acid;Ethylene Oxide;Hydrogen Peroxide

[04048551344385]

Liquid Chemical;Peracetic Acid;Ethylene Oxide;Hydrogen Peroxide

[04048551344385]

Liquid Chemical;Peracetic Acid;Ethylene Oxide;Hydrogen Peroxide

[04048551344385]

Liquid Chemical;Peracetic Acid;Ethylene Oxide;Hydrogen Peroxide

[04048551344385]

Liquid Chemical;Peracetic Acid;Ethylene Oxide;Hydrogen Peroxide

[04048551344385]

Liquid Chemical;Peracetic Acid;Ethylene Oxide;Hydrogen Peroxide

[04048551344385]

Liquid Chemical;Peracetic Acid;Ethylene Oxide;Hydrogen Peroxide

[04048551344385]

Liquid Chemical;Peracetic Acid;Ethylene Oxide;Hydrogen Peroxide

[04048551344385]

Liquid Chemical;Peracetic Acid;Ethylene Oxide;Hydrogen Peroxide

[04048551344385]

Liquid Chemical;Peracetic Acid;Ethylene Oxide;Hydrogen Peroxide

[04048551344385]

Liquid Chemical;Peracetic Acid;Ethylene Oxide;Hydrogen Peroxide

[04048551344385]

Liquid Chemical;Peracetic Acid;Ethylene Oxide;Hydrogen Peroxide

[04048551344385]

Liquid Chemical;Peracetic Acid;Ethylene Oxide;Hydrogen Peroxide

[04048551344385]

Liquid Chemical;Peracetic Acid;Ethylene Oxide;Hydrogen Peroxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2021-05-10
• Device Publish Date: 2016-09-23

On-Brand Devices [Flex-X / IMAGE 1 S]

• 04048551402597: Vid. Uretero-Renoscope FLEX-XC
• 04048551344385: Video Uretero-Renoscope FLEX-XC
• 04048551402603: Vid. Uretero-Renoscope FLEX-XC
• 04048551344408: Video Uretero-Renoscope FLEX-XC