Publix

Basic Information

• Brand Name: Publix
• Primary DI: 00041415009684
• Version / Model: B FMDLS 0130 R02401 PB
• Company Name: U.S. COTTON, LLC
• Labeler DUNS: 932938897
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 130
• Record Status: Published
• Publish Date: 2020-02-28
• Public Version: 2
• Public Version Date: 2022-08-16
• Public Version Status: Update
• Public Device Record Key: c43d66ca-b721-4e9d-be25-ed77b4f639a8
• Distribution End Date: 2022-03-01

Device Description

Sterile Cotton Balls (130ct Medium 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: Yes
• 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
63282	Cotton wool ball, sterile	A sterile, non-dedicated device designed as an absorbent, spherical mass of cotton or man-made fibres intended for use to absorb fluids, typically in a surgical setting. It may be radiopaque to make it visible on x-ray, and may have an attached cord to improve traceability in a surgical setting. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20041415009688	GS1	Case	24	Not in Commercial Distribution	2022-03-01
Primary	00041415009684	GS1
Unit of Use	10048341800016	GS1

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