Dukal

Basic Information

• Brand Name: Dukal
• Primary DI: 00665973027463
• Version / Model: 7007105,7007105-5,7007105-6
• Catalog Number: 7007105,7007105-5,7007105-6
• Company Name: Dukal LLC
• Labeler DUNS: 791014871
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-06
• Public Version: 1
• Public Version Date: 2022-12-14
• Public Version Status: New
• Public Device Record Key: 663c2bd0-0b36-46f7-8a27-b0fffd42854b

Device Description

Burn Gel Sachet

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: 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
47694	Burn gel	A substance intended to be applied directly to a minor burn or sunburn to protect against infection, minimize trauma and skin damage, moisten and cool the burn area, and prevent burn progression. It is typically available in sachets, bottles, or spray containers as a gel or spray and is used by emergency medical services (EMS) and critical care units, but may also be used in the home. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	60665973027465	GS1	Box	6	In Commercial Distribution
Package	20665973027467	GS1	Case	200	In Commercial Distribution
Primary	00665973027463	GS1
Package	50665973027468	GS1	Case	24	In Commercial Distribution
Package	40665973027461	GS1	Box	25	In Commercial Distribution
Package	30665973027464	GS1	case	100	In Commercial Distribution

Customer Contacts

• Phone: [phone] ext. 172
• Email: [email protected]