SureFlex 200

GUDID 00878953004822

200 Lithotripsy Fiber

AMERICAN MEDICAL SYSTEMS

Urogenital surgical laser system beam guide, single-use

• Primary Device ID: 00878953004822
• NIH Device Record Key: c6735680-40a1-4cd7-81b3-29b2b3fe65e1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SureFlex 200
• Version Model Number: S-LLF200TG
• Company DUNS: 796308653
• Company Name: AMERICAN MEDICAL SYSTEMS
• 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: true
• 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 Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00878953004822 [Primary]

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: 5
• Public Version Date: 2019-04-25
• Device Publish Date: 2016-09-24

Devices Manufactured by AMERICAN MEDICAL SYSTEMS

• 00878953004822 - SureFlex 200: 2019-04-25200 Lithotripsy Fiber
• 00878953004822 - SureFlex 200: 2019-04-25 200 Lithotripsy Fiber
• 00878953000015 - AddStat: 2019-02-13
• 00878953000046 - EndoStat: 2019-02-13 0.2mm 12ft
• 00878953000053 - EndoStat: 2019-02-13 0.2mm 12ft SL
• 00878953000060 - EndoStat: 2019-02-13 0.3mm 12ft
• 00878953000077 - EndoStat: 2019-02-13 0.6mm 12ft
• 00878953000084 - EndoStat: 2019-02-13 0.6mm 18ft
• 00878953000091 - EndoStat: 2019-02-13 0.6mm 12ft