Cotton Balls

Basic Information

• Brand Name: Cotton Balls
• Primary DI: 20749915000623
• Version / Model: 31-01
• Company Name: AMERICAN SURGICAL COMPANY, LLC
• Labeler DUNS: 151054954
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 20
• Record Status: Published
• Publish Date: 2016-06-07
• Public Version: 3
• Public Version Date: 2019-11-25
• Public Version Status: Update
• Public Device Record Key: a70e3f50-5198-47b2-98f5-9cea15c6e359

Device Description

Cotton Balls-Non-Strung 3/8"

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GDY	Gauze/Sponge, Internal, X-Ray Detectable	General, Plastic Surgery	878.4450	1

GMDN Terms

Code	Name	Definition	Implantable	Status
11028	Cotton ball	A device designed as an absorbent, non-sterile spherical mass of cotton or man-made fibres used as a swab to apply medications to or remove fluid/liquid from various parts of the body. It is used within the healthcare sector or the home and is normally available [non-prescription] over-the-counter (OTC). This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	20749915000623	GS1
Unit of Use	10749915000626	GS1

Premarket Submissions

Submission Number	Supplement Number
K854714	000