3M™ Ioban™

Basic Information

• Brand Name: 3M™ Ioban™
• Primary DI: 10707387814035
• Version / Model: 8850EZ
• Catalog Number: 8850EZ
• Company Name: 3M COMPANY
• Labeler DUNS: 830016148
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-01-17
• Public Version: 2
• Public Version Date: 2026-03-16
• Public Version Status: Update
• Public Device Record Key: 9ce8f389-58fc-4519-bffd-7860b9e038a3

Device Description

3M™ Ioban™ CHG Chlorohexidine Gluconate Incise Drape (2% w/w CHG), 8850EZ, 22 in x 17 in (56cm x 45cm), 10/CAR, 4 CAR/CS

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: Yes
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
KKX	Drape, surgical	General, Plastic Surgery	878.4370	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47783	Patient surgical drape, single-use	A noninvasive sheet designed to cover a portion of a patient’s anatomy during a surgical procedure to function as a barrier to cross contamination (e.g., isolate a site of surgical incision, protect non-operative anatomy). It is not designed with specific heat-reflective or laser resistant materials. It is available in a variety of designs (e.g., flat sheet with or without an access hole, leg tube or an adhesive film sheet otherwise known as an incise drape). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50707387814033	GS1	Case	4	In Commercial Distribution
Package	30707387814039	GS1	Carton	10	In Commercial Distribution
Primary	10707387814035	GS1

Customer Contacts

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