FTRD prOVE Cap 200.71

GUDID 4260206310617

FTRD application cap for verification of possible application of the colonic FTRD Set (accessability and ability to pull lesion into cap)

Ovesco Endoscopy AG

Endoscopic electrosurgical biopsy/resection cap trial

• Primary Device ID: 4260206310617
• NIH Device Record Key: 1131046b-94e2-4b55-bd21-6e848a6ef14c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FTRD prOVE Cap
• Version Model Number: FTRD 14
• Catalog Number: 200.71
• Company DUNS: 344007369
• Company Name: Ovesco Endoscopy AG
• 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: 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +49707196528160
• Email: service@ovesco.com

Device Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260206310624 [Primary]
GS1	4260206310617 [Package]; Contains: 04260206310624; Package: folding box [2 Units]; In Commercial Distribution

FDA Product Code

• FEI: Instrument, Special Lens, For Endoscope

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-10-31
• Device Publish Date: 2018-10-02

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