3M™ Nu-Gel™

Basic Information

• Brand Name: 3M™ Nu-Gel™
• Primary DI: 04054596954229
• Version / Model: MNG425
• Catalog Number: MNG425
• Company Name: 3M Deutschland GmbH
• Labeler DUNS: 315731711
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 6
• Record Status: Published
• Publish Date: 2023-06-02
• Public Version: 1
• Public Version Date: 2023-06-12
• Public Version Status: New
• Public Device Record Key: 2e868185-8be4-4b62-afaa-df3f45814d5c

Device Description

3M™ Nu-Gel™ Hydrogel with Alginate, MNG425, 0.88 oz (25 g), 6/Ct, 4 Cts/Cs

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• 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: 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
NAE	Dressing, wound, hydrogel without drug and/or biologic	General, Plastic Surgery	878.4022	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47764	Wound hydrogel dressing, non-antimicrobial	A wound covering typically made of cross-linked polymer gels in sheet form or an amorphous hydrating gel of various formulations intended to promote wound healing by maintaining a moist wound environment; it may also facilitate wound debridement and/or absorb exudates in wounds that are minimally to moderately exudative. It may combine hydrogel with supplemental dressing materials (e.g., alginate, film backing), require the use of a secondary dressing, and/or provide a barrier impermeable to liquids and gases; it does not include an antimicrobial agent(s). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	04054596954236	GS1	BOX	1	In Commercial Distribution
Primary	04054596954229	GS1
Unit of Use	04054596954212	GS1

Customer Contacts

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