Sof-Rol®

Basic Information

• Brand Name: Sof-Rol®
• Primary DI: 04042809438468
• Version / Model: 72345-10
• Catalog Number: 72345-10
• Company Name: BSN MEDICAL, INC.
• Labeler DUNS: 026301221
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 20
• Record Status: Published
• Publish Date: 2022-09-27
• Public Version: 2
• Public Version Date: 2022-12-06
• Public Version Status: Update
• Public Device Record Key: 1dd5b549-7f2f-4a45-b35d-028b1248c4c8

Device Description

SOF-ROL STERILE 5CM X 3.6MTR 20

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: 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
ITG	BANDAGE, CAST	Physical Medicine	890.3025	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
Unit of Use	04042809667295	GS1
Primary	04042809438468	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	360	Centimeter
Width	5	Centimeter