TroClear

Basic Information

• Brand Name: TroClear
• Primary DI: B606TC10SPD1
• Version / Model: TC10SPD
• Catalog Number: TC10SPD
• Company Name: Mednium Corporation
• Labeler DUNS: 080614210
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-09-12
• Public Version: 2
• Public Version Date: 2024-10-16
• Public Version Status: Update
• Public Device Record Key: 5c537c0b-87d4-4b8b-9a05-42499fca65c6
• Distribution End Date: 2047-09-11

Device Description

Hospital SPD trocar squeegee cleaning system is a non-sterile multiple use per IFU medical device. TroClear SPD TM cleans debris inside the trocar canula, TroClear TM SPD squeegees the canula clean in a single pass. TroClear TM SPD can be rinsed clean and reused multiple times per IFU.

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: 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: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MNL	Accessories, Cleaning Brushes, For Endoscope	Gastroenterology, Urology	876.1500	1

GMDN Terms

Code	Name	Definition	Implantable	Status
34878	Surgical instrument/endoscope cleaning utensil, reusable	A non-absorbent, non-powered, hand-held device in the form of a brush, a wire, strip of metal, or handle intended to clean the exterior and/or interior (lumen) of a surgical instrument (e.g., bur, reamer, bone tap, suturing device, sheath/shaft, ultrasonic surgical handpiece) and/or endoscope. The bristles, fibres or spines of brushes may be mounted along a single plane or radiate out around a central shaft, and may be soft or stiff; the shaft/handle of brushes may be flexible or rigid. The device may be used to clean endoscopic or open-surgery instruments, and it may have a handle or a connector/adaptor at the proximal end. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	B606TC10SPD6	HIBCC	Box	10	In Commercial Distribution	2027-09-11
Primary	B606TC10SPD1	HIBCC
Package	B606TC10SPD7	HIBCC	Carton	100	In Commercial Distribution	2027-09-11

Customer Contacts

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