Flex-X

GUDID 04048551402634

Video Uretero-Renoscope, FLEX-X C

Karl Storz GmbH & Co. KG

Flexible video ureterorenoscope, reusable Flexible video ureterorenoscope, reusable Flexible video ureterorenoscope, reusable Flexible video ureterorenoscope, reusable Flexible video ureterorenoscope, reusable Flexible video ureterorenoscope, reusable Flexible video ureterorenoscope, reusable Flexible video ureterorenoscope, reusable Flexible video ureterorenoscope, reusable Flexible video ureterorenoscope, reusable Flexible video ureterorenoscope, reusable Flexible video ureterorenoscope, reusable Flexible video ureterorenoscope, reusable Flexible video ureterorenoscope, reusable Flexible video ureterorenoscope, reusable

• Primary Device ID: 04048551402634
• NIH Device Record Key: babc9da5-4881-4cde-a739-0ce0afb09acf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Flex-X
• Version Model Number: 11278VUA
• 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	04048551402634 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131369

FDA Product Code

• FGB: Ureteroscope and accessories, flexible/rigid

Sterilization

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

[04048551402634]

Ethylene Oxide

[04048551402634]

Ethylene Oxide

[04048551402634]

Ethylene Oxide

[04048551402634]

Ethylene Oxide

[04048551402634]

Ethylene Oxide

[04048551402634]

Ethylene Oxide

[04048551402634]

Ethylene Oxide

[04048551402634]

Ethylene Oxide

[04048551402634]

Ethylene Oxide

[04048551402634]

Ethylene Oxide

[04048551402634]

Ethylene Oxide

[04048551402634]

Ethylene Oxide

[04048551402634]

Ethylene Oxide

[04048551402634]

Ethylene Oxide

[04048551402634]

Ethylene Oxide

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]

• 04048551416976: Video Uretero-Renoscope FLEX-X C
• 04048551416969: Video Uretero-Renoscope FLEX-X C
• 04048551402634: Video Uretero-Renoscope, FLEX-X C
• 04048551278239: Video Uretero-Renoscope, FLEX-X C
• 04048551338988: Video Neuro-Endoscope, flexible