Ritus

Basic Information

• Brand Name: Ritus
• Primary DI: 10884521811256
• Version / Model: 8888415661
• Company Name: Covidien LP
• Labeler DUNS: 058614483
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-08-28
• Public Version: 3
• Public Version Date: 2023-06-15
• Public Version Status: Update
• Public Device Record Key: 57860884-8d77-4888-90a0-40eb474b5903

Device Description

Peritoneal Dialysis Accessory Catheter Straightening Stylet

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: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FJS	Catheter, peritoneal, long-term indwelling	Gastroenterology, Urology	876.5630	2

GMDN Terms

Code	Name	Definition	Implantable	Status
13837	Peritoneal catheter stylet	A thin wire/rod intended to be inserted within the lumen of a peritoneal catheter (e.g., peritoneal dialysis catheter, peritoneal drainage catheter, peritoneal lavage catheter, abdominal fluid shunt system peritoneal catheter) to stiffen/maintain the shape of the catheter to assist introduction; it may also be intended to assist insertion of a bladder catheter used for drainage of fluid from the peritoneal cavity to the bladder. It is intended to be removed once the catheter is in place. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10884521811256	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K920515	000

Device Sizes

Type	Value	Unit	Text
Length	61	Centimeter