H&H

Basic Information

• Brand Name: H&H
• Primary DI: 04719884330108
• Version / Model: HW2106
• Catalog Number: HW2106
• 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: 2
• Public Version Date: 2024-02-16
• Public Version Status: Update
• Public Device Record Key: 606f0015-6bd1-43d2-9dd8-772cc860fa6d

Device Description

Hydration healing for wounds 1. absorbing exudate (reduce the number of dressing changes, to avoid interference with wound healing) 2. Non-adherent and Non-linting (Easy to remove, won’t cause wound trama) 3. Perfect conformity (Conform to wound’s figure perfectly, patients feel comfortable in their daily movements)

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
47771	Scar-management dressing, single-use	A covering/substance made of, or coated with, a synthetic polymer material (e.g., silicone gel) intended to be applied directly to the skin for the management of hypertrophic or keloid scars. The device is typically in the form of a flexible or elastic sheet/film, foam, or gel that occludes the skin to hydrate and reduce/prevent red, dark, or raised scars resulting from surgery, accidents, cuts, burns, or other injuries. The device may be self-adhesive or fixed by tape; devices/accessories associated with application may be included (e.g., massage ball). 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	04719884330139	GS1	Box	6	In Commercial Distribution
Primary	04719884330108	GS1
Package	04719884330306	GS1	Box	72	In Commercial Distribution
Previous	04719859641901	GS1

Device Sizes

Type	Value	Unit	Text
Length	21	Centimeter
Width	6	Centimeter