TROPHYscope

GUDID 04048551276006

CAMPO TROPHYSCOPE®

Karl Storz GmbH & Co. KG

Rigid optical hysteroscope Rigid optical hysteroscope Rigid optical hysteroscope Rigid optical hysteroscope Rigid optical hysteroscope Rigid optical hysteroscope Rigid optical hysteroscope Rigid optical hysteroscope Rigid optical hysteroscope Rigid optical hysteroscope Rigid optical hysteroscope Rigid optical hysteroscope Rigid optical hysteroscope Rigid optical hysteroscope Rigid optical hysteroscope Rigid optical hysteroscope Rigid optical hysteroscope Rigid optical hysteroscope

• Primary Device ID: 04048551276006
• NIH Device Record Key: c718da12-bd03-43c2-883f-b1005a66ebcc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TROPHYscope
• Version Model Number: 26008BAC
• Company DUNS: 315731430
• Company Name: Karl Storz GmbH & Co. KG
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	04048551276006 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K971518

FDA Product Code

• HIH: HYSTEROSCOPE (AND ACCESSORIES)

Sterilization

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

[04048551276006]

Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide

[04048551276006]

Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide

[04048551276006]

Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide

[04048551276006]

Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide

[04048551276006]

Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide

[04048551276006]

Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide

[04048551276006]

Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide

[04048551276006]

Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide

[04048551276006]

Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide

[04048551276006]

Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide

[04048551276006]

Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide

[04048551276006]

Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide

[04048551276006]

Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide

[04048551276006]

Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide

[04048551276006]

Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide

[04048551276006]

Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide

[04048551276006]

Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide

[04048551276006]

Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-11-08
• Device Publish Date: 2016-09-23

On-Brand Devices [TROPHYscope]

• 04048551276006: CAMPO TROPHYSCOPE®
• 04048551346396: TROPHY Curette