U.S. Cotton

Basic Information

• Brand Name: U.S. Cotton
• Primary DI: 00095859100162
• Version / Model: L FZUSS 0160 R01201 US
• Catalog Number: L FZUSS 0160 R01201 US
• Company Name: U.S. COTTON, LLC
• Labeler DUNS: 932938897
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-02-28
• Public Version: 2
• Public Version Date: 2022-09-21
• Public Version Status: Update
• Public Device Record Key: db45519d-e29a-4511-9512-773e065a1e42
• Distribution End Date: 2022-08-19

Device Description

Sterile Cotton Roll (16 oz)

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
58233	Cotton wool roll, sterile	A device designed as an absorbent, sterile mass of cotton or man-made fibres formed in a continuous length (roll) and typically used as a general-purpose absorbent or padding within the healthcare sector; it is not in the form of a bandage or dedicated dressing. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10095859100169	GS1	Case	12	Not in Commercial Distribution	2022-08-19
Primary	00095859100162	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