Video Camera Insert

GUDID 00878953007656

Video Camera Insert/Filter For Rigid Endoscope

AMERICAN MEDICAL SYSTEMS

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• Primary Device ID: 00878953007656
• NIH Device Record Key: 8960d4ed-5fd0-4d64-9817-d2e9ed2a3489
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Video Camera Insert
• Version Model Number: 0010-0728
• 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: false
• Serial Number: true
• 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

• 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	00878953007656 [Primary]

FDA Product Code

• FEM: Accessories, Photographic, For Endoscope (Exclude Light Sources)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-02-13
• Device Publish Date: 2018-10-03

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