TopCare health

Basic Information

• Brand Name: TopCare health
• Primary DI: 00036800186811
• Version / Model: 036800186811
• Company Name: TOPCO ASSOCIATES, LLC
• Labeler DUNS: 072943876
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 24
• Record Status: Published
• Publish Date: 2020-07-13
• Public Version: 2
• Public Version Date: 2021-08-24
• Public Version Status: Update
• Public Device Record Key: 96a8f70c-3301-4772-b9cd-1ffaeb12bfc9

Device Description

Sterile Gauze Pads, all one size, 4 IN x 4 IN (10.1 cm x 10.1 cm)

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
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	878.4014	1

GMDN Terms

Code	Name	Definition	Implantable	Status
48131	Non-woven gauze pad	A non-medicated device in the form of a patch or swab (also referred to as a sponge) made from non-woven material (e.g., rayon/polyester) and primarily designed to absorb fluids for medical purposes. It is typically used to cover/clean wounds or abrasions and absorb their exudates, absorb body-surface exudates, or to apply topical medications; it is intended to produce less lint and be less adherent than basic woven gauze pads; it does not include petrolatum. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10036800340326	GS1	case	36	In Commercial Distribution
Primary	00036800186811	GS1
Unit of Use	60036800186813	GS1

Customer Contacts

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