Cotton Rolls

Basic Information

• Brand Name: Cotton Rolls
• Primary DI: 10732224000043
• Version / Model: DNC
• Company Name: CROSSTEX INTERNATIONAL, INC.
• Labeler DUNS: 057728685
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 2000
• Record Status: Published
• Publish Date: 2022-08-25
• Public Version: 2
• Public Version Date: 2023-09-14
• Public Version Status: Update
• Public Device Record Key: dd096a40-9326-46f9-a7a5-c3f22e15569a

Device Description

Cotton Rolls Non-Sterile, #2 Medium 1.5"x.375"/4x1 cm

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: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EFN	COTTON, ROLL	Dental	872.6050	1

GMDN Terms

Code	Name	Definition	Implantable	Status
48127	Woven gauze roll/sheet	A device in the form of a long length of stretchable, absorbent, woven material (e.g., cotton, cellulose), wound into a roll or folded, and typically designed for a variety of applications (non-dedicated) such as a primary wound dressing, dressing retention, and injury padding and compression. It is not a dedicated pressure dressing and does not include latex. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50732224004063	GS1		12	In Commercial Distribution
Primary	10732224000043	GS1
Unit of Use	00732224000046	GS1

Customer Contacts

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