TopCare Health

Basic Information

• Brand Name: TopCare Health
• Primary DI: 00036800281783
• Version / Model: 67856TC1
• Company Name: TOPCO ASSOCIATES, LLC
• Labeler DUNS: 072943876
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-08-10
• Public Version: 1
• Public Version Date: 2020-08-18
• Public Version Status: New
• Public Device Record Key: 97064b99-f11d-4b6b-b05f-dd5c435dd99d

Device Description

TOP CARE SFTY SHIELD TAB CUTER

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• 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
OHY	Pill Crusher/Cutter	General Hospital	880.6430	1

GMDN Terms

Code	Name	Definition	Implantable	Status
15750	Pill crusher/splitter	A hand-held device designed for crushing or splitting in two medication in the form of a tablet for easier ingestion by a patient who cannot swallow the tablet whole. It is designed for convenience to be carried in the user's pocket or handbag (purse) and typically consists of several pieces that can be easily assembled by the user to crush or split the pill (tablet) by screwing the two main body parts against each other. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20025715011152	GS1	Bag	6	In Commercial Distribution
Primary	00036800281783	GS1
Package	10036800281780	GS1	Case	12	In Commercial Distribution

Customer Contacts

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