BETTOCCHI 26159N

GUDID 04048551094440

BETTOCCHI Needle Electrode, 5 Fr.

Karl Storz GmbH & Co. KG

Endoscopic electrosurgical electrode, monopolar, reusable

• Primary Device ID: 04048551094440
• NIH Device Record Key: 63e647e3-9dea-4dbd-b84d-e056eb516415
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BETTOCCHI
• Version Model Number: 26159N
• Catalog Number: 26159N
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04048551094440 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K944793

FDA Product Code

• KNF: COAGULATOR-CUTTER, ENDOSCOPIC, UNIPOLAR (AND ACCESSORIES)

Sterilization

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

[04048551094440]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[04048551094440]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[04048551094440]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[04048551094440]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[04048551094440]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[04048551094440]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[04048551094440]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[04048551094440]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[04048551094440]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[04048551094440]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[04048551094440]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[04048551094440]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[04048551094440]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[04048551094440]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[04048551094440]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[04048551094440]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[04048551094440]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2024-07-31
• Device Publish Date: 2016-09-23

On-Brand Devices [BETTOCCHI]

• 04048551094426: BETTOCCHI Myome Fixation Instrument,5 Fr
• 04048551094440: BETTOCCHI Needle Electrode, 5 Fr.
• 04048551094303: Palpation Probe, 5 Fr.