EndoStat

GUDID 00878953000046

0.2mm 12ft

AMERICAN MEDICAL SYSTEMS

General/multiple surgical laser system beam guide, reusable

• Primary Device ID: 00878953000046
• NIH Device Record Key: ed972da0-2ed3-4299-aabb-01aa9b153da1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EndoStat
• Version Model Number: 0010-0952
• 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

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00878953000046 [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 [EndoStat]

• 00878953000107: 0.4mm 12ft
• 00878953000091: 0.6mm 12ft
• 00878953000084: 0.6mm 18ft
• 00878953000077: 0.6mm 12ft
• 00878953000060: 0.3mm 12ft
• 00878953000053: 0.2mm 12ft SL
• 00878953000046: 0.2mm 12ft