GUDID 00878953000213

Microstat, 9cm Curved Surgical Laser Handpieces

AMERICAN MEDICAL SYSTEMS

Laser beam delivery unit holder

• Primary Device ID: 00878953000213
• NIH Device Record Key: 7fa04893-0570-423d-81cb-fcdece47251f
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 0010-0814
• Company DUNS: 796308653
• Company Name: AMERICAN MEDICAL SYSTEMS
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• 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

• Length: 9 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00878953000213 [Primary]

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00878953000213]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-02-13
• Device Publish Date: 2016-09-24

Devices Manufactured by AMERICAN MEDICAL SYSTEMS

• 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