CALCUSON 27085TW

GUDID 04048551079799

Wrench

Karl Storz GmbH & Co. KG

Ultrasonic lithotripsy system

• Primary Device ID: 04048551079799
• NIH Device Record Key: b1eeaf95-1533-488f-8f30-667084ee6211
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CALCUSON
• Version Model Number: 27085TW
• Catalog Number: 27085TW
• 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: true
• Serial Number: false
• 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
• 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	04048551079799 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K843101

FDA Product Code

• FEO: Lithotriptor, ultrasonic

Sterilization

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

[04048551079799]

Moist Heat or Steam Sterilization

[04048551079799]

Moist Heat or Steam Sterilization

[04048551079799]

Moist Heat or Steam Sterilization

[04048551079799]

Moist Heat or Steam Sterilization

[04048551079799]

Moist Heat or Steam Sterilization

[04048551079799]

Moist Heat or Steam Sterilization

[04048551079799]

Moist Heat or Steam Sterilization

[04048551079799]

Moist Heat or Steam Sterilization

[04048551079799]

Moist Heat or Steam Sterilization

[04048551079799]

Moist Heat or Steam Sterilization

[04048551079799]

Moist Heat or Steam Sterilization

[04048551079799]

Moist Heat or Steam Sterilization

[04048551079799]

Moist Heat or Steam Sterilization

[04048551079799]

Moist Heat or Steam Sterilization

[04048551079799]

Moist Heat or Steam Sterilization

[04048551079799]

Moist Heat or Steam Sterilization

[04048551079799]

Moist Heat or Steam Sterilization

[04048551079799]

Moist Heat or Steam Sterilization

[04048551079799]

Moist Heat or Steam Sterilization

[04048551079799]

Moist Heat or Steam Sterilization

[04048551079799]

Moist Heat or Steam Sterilization

[04048551079799]

Moist Heat or Steam Sterilization

[04048551079799]

Moist Heat or Steam Sterilization

[04048551079799]

Moist Heat or Steam Sterilization

[04048551079799]

Moist Heat or Steam Sterilization

[04048551079799]

Moist Heat or Steam Sterilization

[04048551079799]

Moist Heat or Steam Sterilization

[04048551079799]

Moist Heat or Steam Sterilization

[04048551079799]

Moist Heat or Steam Sterilization

[04048551079799]

Moist Heat or Steam Sterilization

[04048551079799]

Moist Heat or Steam Sterilization

[04048551079799]

Moist Heat or Steam Sterilization

[04048551079799]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2024-07-31
• Device Publish Date: 2016-09-23

On-Brand Devices [CALCUSON]

• 04048551079799: Wrench
• 04048551085820: CALCUSON Ultrasonic Generator
• 04048551083291: Ultrasonic Lithotripsy Probe
• 04048551083277: Ultrasonic Lithotripsy Probe