colonic FTRD prOVE Cap

Basic Information

• Brand Name: colonic FTRD prOVE Cap
• Primary DI: 04260206311157
• Version / Model: FTRD 14
• Catalog Number: 200.71
• Company Name: Ovesco Endoscopy AG
• Labeler DUNS: 344007369
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-03-08
• Public Version: 2
• Public Version Date: 2019-10-31
• Public Version Status: Update
• Public Device Record Key: 8c2c5887-a2d9-4dad-a574-b4ffae4d8ff4

Device Description

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

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FEI	Instrument, Special Lens, For Endoscope	Gastroenterology, Urology	876.1500	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64092	Endoscopic electrosurgical biopsy/resection cap trial	A copy of the distal endoscopic cap used in a full-thickness endoscopic electrosurgical biopsy/resection kit, intended to be used to determine if the treatment cap is of the correct size to reach the lesion and for the lesion to be pulled into the cap in order to be resected. It is in the form of a clear plastic tube designed to be placed onto the distal end of an endoscope. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Previous	04260206310624	GS1
Package	04260206311140	GS1	folding box	2	In Commercial Distribution
Primary	04260206311157	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]
• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			endoscope diameter 11.5-13.2 mm