Twister™ Side-Fire Fiber Optic Delivery System 101315

GUDID 04049089300225

Ceram Optec SIA

Urogenital surgical laser system beam guide, single-use

• Primary Device ID: 04049089300225
• NIH Device Record Key: 3bd9c6d7-4582-4a6c-819e-2c4fd8b8ef93
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Twister™ Side-Fire Fiber Optic Delivery System
• Version Model Number: Twister™ XXL
• Catalog Number: 101315
• Company DUNS: 506069240
• Company Name: Ceram Optec SIA
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04049089100221 [Primary]
GS1	04049089200228 [Package]; Contains: 04049089100221; Package: Box [1 Units]; In Commercial Distribution
GS1	04049089300225 [Package]; Contains: 04049089200228; Package: Box [5 Units]; In Commercial Distribution

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: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-03-09

On-Brand Devices [Twister™ Side-Fire Fiber Optic Delivery System]

• 04049089300225: Twister™ XXL
• 04049089300201: Twister™ XL
• 04049089300188: Twister™ L
• 04049089300164: Twister™ Slim
• 04049089300140: Twister™