Twister 101258-IC

GUDID 00859337007103

lateral emitting laser fiber

WISDOM MEDICAL TECHNOLOGY, LLC

General/multiple surgical laser system beam guide, reusable

• Primary Device ID: 00859337007103
• NIH Device Record Key: b5a12994-2b34-4875-b980-ed6b10aaf45b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Twister
• Version Model Number: 101258-IC
• Catalog Number: 101258-IC
• Company DUNS: 080537625
• Company Name: WISDOM MEDICAL TECHNOLOGY, LLC
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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: 630-803-6383
• Email: jfurcht@verizon.net
• Phone: 630-803-6383
• Email: jfurcht@verizon.net
• Phone: 630-803-6383
• Email: jfurcht@verizon.net
• Phone: 630-803-6383
• Email: jfurcht@verizon.net
• Phone: 630-803-6383
• Email: jfurcht@verizon.net
• Phone: 630-803-6383
• Email: jfurcht@verizon.net
• Phone: 630-803-6383
• Email: jfurcht@verizon.net
• Phone: 630-803-6383
• Email: jfurcht@verizon.net
• Phone: 630-803-6383
• Email: jfurcht@verizon.net
• Phone: 630-803-6383
• Email: jfurcht@verizon.net
• Phone: 630-803-6383
• Email: jfurcht@verizon.net
• Phone: 630-803-6383
• Email: jfurcht@verizon.net
• Phone: 630-803-6383
• Email: jfurcht@verizon.net
• Phone: 630-803-6383
• Email: jfurcht@verizon.net
• Phone: 630-803-6383
• Email: jfurcht@verizon.net
• Phone: 630-803-6383
• Email: jfurcht@verizon.net
• Phone: 630-803-6383
• Email: jfurcht@verizon.net
• Phone: 630-803-6383
• Email: jfurcht@verizon.net
• Phone: 630-803-6383
• Email: jfurcht@verizon.net
• Phone: 630-803-6383
• Email: jfurcht@verizon.net
• Phone: 630-803-6383
• Email: jfurcht@verizon.net
• Phone: 630-803-6383
• Email: jfurcht@verizon.net
• Phone: 630-803-6383
• Email: jfurcht@verizon.net
• Phone: 630-803-6383
• Email: jfurcht@verizon.net
• Phone: 630-803-6383
• Email: jfurcht@verizon.net
• Phone: 630-803-6383
• Email: jfurcht@verizon.net
• Phone: 630-803-6383
• Email: jfurcht@verizon.net

Device Identifiers

Device Issuing Agency	Device ID
GS1	00859337007103 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112987

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-10-29
• Device Publish Date: 2018-09-26

On-Brand Devices [Twister]

• 00869851000306: lateral emitting laser fiber
• 00859337007103: lateral emitting laser fiber
• 00859337007035: lateral emitting laser fiber