H&H

Primary DI: 04719859642014
Brand: H&H
Company: TRONJEN MEDICAL TECHNOLOGY INC.
Model: SH1206
Catalog number: SH1206
Device description: Effective treatment for scar 1. Maintain proper moist environment 2. Support and close the wound 3. Tissue well arrayed, reduce scar proliferation.
Published: 2020-06-12
Public version status: Update
Distribution status: In Commercial Distribution
MRI safety: Labeling does not contain MRI Safety Information
Rx: false
OTC: true
Sterile: true
Single use: true

Related Records

Contact Domains

ad-surgical.com

Product Codes

Code	Name
NAD	Dressing, Wound, Occlusive

Product Code Classifications

Code	Device	Specialty	Class
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	1

Identifiers And Packaging

Identifier	Type	Agency	Package quantity	Status
04719859642014	Package	GS1	6	In Commercial Distribution
04719859642038	Primary	GS1	0

Alternate GTIN / UPC / EAN Codes

Source identifier	GTIN-14 normalized	EAN-13
04719859642014	04719859642014	4719859642014
04719859642038	04719859642038	4719859642038

GMDN Terms

Term	Definition
Scar management dressing, single-use, non-sterile	A non-sterile covering/substance made of, or coated with, a synthetic polymer material (e.g., silicone gel, polyurethane) 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.

Term

Definition

Scar management dressing, single-use, non-sterile

A non-sterile covering/substance made of, or coated with, a synthetic polymer material (e.g., silicone gel, polyurethane) 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.

Device Sizes

Type	Value	Unit
Length	12	Centimeter
Width	6	Centimeter

Sterilization Methods

Method
Radiation Sterilization

Contacts

Phone	Email
4085411393	vera@ad-surgical.com

Regulatory Flags

DUNS number: 657496877
Device count: 1
DM exempt: false
Premarket exempt: true
HCT/P: false
Kit: false
Combination product: false
Lot or batch: true
Serial number: false
Manufacturing date on label: true
Expiration date on label: true
Donation ID number: false
Contains natural rubber latex: false
No natural rubber latex: true
Sterilization required before use: true

Other Devices From This Company

Primary DI	Brand	Model	Catalog	Published
04719884330269	H&H	SC2106		2025-12-12
04719884330368	H&H	SC2106		2025-12-12
04719884333765	H&H	SG0007		2025-12-11
04719884330139	H&H	HW2106	HW2106	2023-07-20
04719884330146	H&H	HW1206	HW1206	2023-07-20
04719884330153	H&H	HW0505	HW0505	2023-07-20
04719884330214	H&H	SH1206	SH1206	2023-07-20
04719884330221	H&H	SH0505	SH0505	2023-07-20
04719884330207	H&H	SH2106	SH2106	2023-07-20
04719884331402	H&H	WG0030	WG0030	2023-07-20
04719859641932	H&H	HW2106	HW2106	2020-06-12
04719859641949	H&H	HW1206	HW1206	2020-06-12
04719859641956	H&H	HW0505	HW0505	2020-06-12
04719859642021	H&H	SH0505	SH0505	2020-06-12
04719859642007	H&H	SH2106	SH2106	2020-06-12

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