TopCare health

Basic Information

• Brand Name: TopCare health
• Primary DI: 00036800117976
• Version / Model: 036800117976
• Company Name: TOPCO ASSOCIATES, LLC
• Labeler DUNS: 072943876
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 12
• Record Status: Published
• Publish Date: 2019-11-28
• Public Version: 1
• Public Version Date: 2019-12-06
• Public Version Status: New
• Public Device Record Key: 0e380408-a036-43e7-a5c3-bd3f9911835e

Device Description

Sterile Butterfly Closures, all one size, 1 3/4 IN x 3/8 IN

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KGX	Tape And Bandage, Adhesive	General Hospital	880.5240	1

GMDN Terms

Code	Name	Definition	Implantable	Status
34865	Butterfly skin-closure adhesive strip	A small, narrow piece of flexible material covered on one side with a pressure-sensitive adhesive, and with broad, wing-shaped ends that function to approximate the edges of a superficial wound. The device may be hypoallergenic and/or waterproof. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10036800117973	GS1	case	72	In Commercial Distribution
Primary	00036800117976	GS1
Unit of Use	60036800117978	GS1