SureFlex

GUDID 00878953000138

150 µm Lithotripsy Fiber

AMERICAN MEDICAL SYSTEMS

Urogenital surgical laser system beam guide, single-use

• Primary Device ID: 00878953000138
• NIH Device Record Key: 81c583b3-a7af-4f9d-93af-ebcd6d35aa53
• Commercial Distribution Discontinuation: 2019-01-23
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: SureFlex
• Version Model Number: 8011032
• 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	00878953000138 [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: 4
• Public Version Date: 2019-02-13
• Device Publish Date: 2016-09-24

On-Brand Devices [SureFlex]

• 00878953004815: 150 Lithotripsy Fiber
• 00878953000190: 910 µm Lithotripsy Fiber
• 00878953000183: 550 µm Lithotripsy Fiber
• 00878953000169: 365 µm Lithotripsy Fiber
• 00878953000152: 273 µm Lithotripsy Fiber
• 00878953000145: 200 µm Lithotripsy Fiber
• 00878953000138: 150 µm Lithotripsy Fiber