U.S. Cotton

Basic Information

• Brand Name: U.S. Cotton
• Primary DI: 00095859110505
• Version / Model: B PXDL 0500 R00401 US
• Catalog Number: B PXDL 0500 R00401 US
• Company Name: U.S. COTTON, LLC
• Labeler DUNS: 932938897
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 500
• Record Status: Published
• Publish Date: 2020-02-28
• Public Version: 4
• Public Version Date: 2023-09-21
• Public Version Status: Update
• Public Device Record Key: fd059735-5500-4699-9cc2-0c9b1bd7b5f0
• Distribution End Date: 2023-08-31

Device Description

Cotton Balls (500ct X-large Size)

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: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• 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
FRL	Fiber, Medical, Absorbent	General Hospital	880.5300	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63281	Cotton wool ball	A non-dedicated device designed as an absorbent, spherical mass of cotton or man-made fibres intended for use as a swab to apply medications to or remove fluid/liquid from various parts of the body. It is intended for use in the home or a clinical setting. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00095859110505	GS1
Unit of Use	10048341800061	GS1
Package	10095859110502	GS1	Case	4	Not in Commercial Distribution	2023-08-31

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store indoors under normal ambient conditions in sealed package