H&H

Basic Information

• Brand Name: H&H
• Primary DI: 04719884331402
• Version / Model: WG0030
• Catalog Number: WG0030
• Company Name: TRONJEN MEDICAL TECHNOLOGY INC.
• Labeler DUNS: 657496877
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-07-20
• Public Version: 1
• Public Version Date: 2023-07-28
• Public Version Status: New
• Public Device Record Key: 0c63b2b1-610d-4ce3-853d-92c1bd2db2f6

Device Description

"H&H" Wound Gel (Sterile) is a transparent gel dressing with an amorphous structure, suitable for irregularly shaped wounds. The formulation is designed to achieve isotonicity, allowing the gel to cover the wound bed, providing a moist wound healing environment, and promoting the migration of new epidermal cells. Carboxymethyl cellulose, combined with glycerol and hyaluronic acid, not only helps absorb wound exudate and blood but also forms a moist gel protective layer on the wound bed, providing an optimal moist healing environment while reducing the risk of infection by acting as a barrier to foreign materials.

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: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Radiation Sterilization

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
Primary	04719884331402	GS1
Package	04719884331426	GS1	Box	16	In Commercial Distribution

Device Sizes

Type	Value	Unit	Text
Total Volume	30	Milliliter