TRUCLEARTM Control Unit

Basic Information

• Brand Name: TRUCLEARTM Control Unit
• Primary DI: 03596010501929
• Version / Model: 7209808
• Catalog Number: 7209808
• Company Name: Smith & Nephew, Inc.
• Labeler DUNS: 045483575
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-08-30
• Public Version: 3
• Public Version Date: 2023-09-07
• Public Version Status: Update
• Public Device Record Key: 208271a8-ee85-4ab3-974e-5071d57c24e9

Device Description

TRUCLEAR CONTROL UNIT

Device Characteristics

• Single Use: No
• 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: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• 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
HIH	HYSTEROSCOPE (AND ACCESSORIES)	Obstetrics/Gynecology	884.1690	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46730	Tissue morcellation system control unit	A mains electricity (AC-powered) component of a tissue morcellation system used to power and regulate the system's handpiece blade via cable connection; some designs may also provide suction intended for removal of resected tissue. This device will typically have hand and/or foot controls.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	03596010501929	GS1

Customer Contacts

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