Clik-FIX

Basic Information

• Brand Name: Clik-FIX
• Primary DI: 00850933007290
• Version / Model: FCS-1075
• Catalog Number: FCS-1075
• Company Name: STARBOARD MEDICAL, INC.
• Labeler DUNS: 012983893
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-04-18
• Public Version: 1
• Public Version Date: 2019-04-26
• Public Version Status: New
• Public Device Record Key: c22748b9-a78c-4a2d-9427-f58f156ce8f2

Device Description

Foley Catheter Securement device for 5-8 Fr.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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
EYJ	Holder, Ureteral Catheter	Gastroenterology, Urology	876.5130	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63012	Urinary catheter holder, sterile	A sterile device designed to be attached to a patient's body to hold an indwelling urinary catheter (e.g., Foley, ureteral), or a tube attached to it, in place. It typically consists of a wrap placed around the patient's thigh, abdomen, or pubis. The holder includes appropriate mechanisms or attachments that can hold the tube or catheter (e.g., integrated Velcro hook/loop closure, spring tensioner) without creating excessive pressure on it and permitting visual inspection of the site. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10850933007297	GS1	Box	50	In Commercial Distribution
Primary	00850933007290	GS1