DermaCol Healogics by DermaRite

Basic Information

• Brand Name: DermaCol Healogics by DermaRite
• Primary DI: 00714196933119
• Version / Model: 93311
• Company Name: DERMARITE INDUSTRIES LLC
• Labeler DUNS: 883925562
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2020-01-28
• Public Version: 2
• Public Version Date: 2023-10-02
• Public Version Status: Update
• Public Device Record Key: 5bae795b-6c33-4329-aec4-55f7a08fe313

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: 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: Yes
• 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
34083	Biochemically-interactive dressing	A sterile, wound-covering substance or material (e.g., ointment, collagen matrix) intended to actively promote the healing of a wound through the temporary modification of a local biochemical parameter(s) or process(es) [e.g., a change to wound pH, enzymatic activity, or protein binding activity]. The device may be used for various types of partial- and full-thickness wounds, draining wounds, sores/ulcers, skin lacerations/abrasions, burns, or surgical wounds. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00714196933119	GS1
Unit of Use	01714196933118	GS1