MEDIHONEY®

Basic Information

• Brand Name: MEDIHONEY®
• Primary DI: 10381780486893
• Version / Model: 31840
• Catalog Number: 31840
• Company Name: ACELL, INC.
• Labeler DUNS: 137258252
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-03-07
• Public Version: 5
• Public Version Date: 2023-05-12
• Public Version Status: Update
• Public Device Record Key: 8aab7a5c-4207-46e7-a1a6-9eee315ec5c5

Device Description

Gel Dressing with Active Leptospermum Honey

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: No
• 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
FRO	Dressing, wound, drug	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
47773	Medical honey liquid barrier dressing	A material formed from medical grade honey intended to protect wounds or tissue surfaces by providing a non-occlusive external barrier to bacteria and the environment. It also helps to maintain a moist internal environment for wounds to assist the healing process. The material may be liquid or semi-liquid and is typically applied directly to the wound or tissue surface (e.g., ocular surface). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30381780486897	GS1	Case	6	In Commercial Distribution
Primary	10381780486893	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			14 oz
Device Size Text, specify			400g

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 59 – 86 Degrees Fahrenheit
• Type: Storage Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius