Twister™ Side-Fire Fiber Optic Delivery System 101185

GUDID 04049089300164

Ceram Optec SIA

Urogenital surgical laser system beam guide, single-use

• Primary Device ID: 04049089300164
• NIH Device Record Key: 40f4a58b-ff9e-4ae0-b608-0f0fe2f1e720
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Twister™ Side-Fire Fiber Optic Delivery System
• Version Model Number: Twister™ Slim
• Catalog Number: 101185
• 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	04049089100160 [Primary]
GS1	04049089200167 [Package]; Contains: 04049089100160; Package: Box [1 Units]; In Commercial Distribution
GS1	04049089300164 [Package]; Contains: 04049089200167; 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: 2017-01-31

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

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