Twister L 101220

GUDID 00869851000313

lateral emitting laser fiber

WISDOM MEDICAL TECHNOLOGY, LLC

General/multiple surgical laser system beam guide, reusable

• Primary Device ID: 00869851000313
• NIH Device Record Key: 47a12d2b-ba37-4bd2-9664-d449d86d6efc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Twister L
• Version Model Number: 101220
• Catalog Number: 101220
• 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	00869851000313 [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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-06-20

On-Brand Devices [Twister L]

• 00869851000344: lateral emitting laser fiber
• 00869851000313: lateral emitting laser fiber
• 00859337007141: lateral emitting laser fiber