CS FlexiFin™ Max Stirrups - Hook & Loop - Left (Stirrup Only)

Basic Information

• Brand Name: CS FlexiFin™ Max Stirrups - Hook & Loop - Left (Stirrup Only)
• Primary DI: 05060624125928
• Version / Model: CSM3027
• Catalog Number: CSM3027
• Company Name: CARE SURGICAL LIMITED
• Labeler DUNS: 221313015
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-03-28
• Public Version: 1
• Public Version Date: 2025-04-07
• Public Version Status: New
• Public Device Record Key: 9fac3f34-5cef-4c92-badd-e85beee77627

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: Yes
• 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: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EYD	Stirrups	Gastroenterology, Urology	876.4890	1

GMDN Terms

Code	Name	Definition	Implantable	Status
65180	Operating table patient positioning set, reusable	A collection of devices intended to support and stabilize in a desired position a patient, or their body parts, on an operating table during a medical procedure (e.g., bariatric surgery, orthopaedic surgery, endotracheal tube intubation); some types may be intended to prevent a patient from sliding while in the Trendelenburg position or when applying traction. The set consists of multiple items which include two or more of the following: a base plate/bar that serves as a foundation to which patient positioners are attached, clamps/adaptors, and disposable/reusable padded positioners dedicated to a body part (e.g., non-slip positioning pad, headrest). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05060624125928	GS1