Fistula Brush

Basic Information

• Brand Name: Fistula Brush
• Primary DI: 04260206310631
• Version / Model: Proctology
• Catalog Number: 200.62
• Company Name: Ovesco Endoscopy AG
• Labeler DUNS: 344007369
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-16
• Public Version: 4
• Public Version Date: 2019-10-31
• Public Version Status: Update
• Public Device Record Key: 8d52cd84-a475-4682-896a-78dede861832

Device Description

The Fistula Brush can be used for probing of the fistula tract and for debridement before using the OTSC Proctology • it is used to clean the fistula tract and remove granulation tissue • supports obliteration of fistula tract

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
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46388	General-purpose cytology brush	A sterile device consisting of tufts or bristles set into a handle that is intended to collect cells from an area of the body, typically during an open surgical procedure. The cells are used for histopathological analysis. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04260206310631	GS1
Package	4260206310280	GS1	Folding box	5	In Commercial Distribution

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			working length 30 cm