FDA.report

H&H

Primary DI
04719884330146
Brand
H&H
Company
TRONJEN MEDICAL TECHNOLOGY INC.
Model
HW1206
Catalog number
HW1206
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)
Published
2023-07-20
Public version status
New
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

Product Codes

CodeName
NAEDressing, Wound, Hydrogel Without Drug And/Or Biologic

Product Code Classifications

CodeDeviceSpecialtyClass
NAEDressing, Wound, Hydrogel Without Drug And/Or BiologicGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04719884330146PackageGS16In Commercial Distribution
04719884330313PackageGS1108In Commercial Distribution
04719859641918PreviousGS10
04719884330115PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04719884330146047198843301464719884330146
04719884330313047198843303134719884330313
04719859641918047198596419184719859641918
04719884330115047198843301154719884330115

GMDN Terms

TermDefinition
Scar management dressing, single-use, non-sterileA 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

TypeValueUnit
Length12Centimeter
Width6Centimeter

Sterilization Methods

Method
Radiation Sterilization

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 DIBrandModelCatalogPublished
04719884330269H&HSC21062025-12-12
04719884330368H&HSC21062025-12-12
04719884333765H&HSG00072025-12-11
04719884330139H&HHW2106HW21062023-07-20
04719884330153H&HHW0505HW05052023-07-20
04719884330214H&HSH1206SH12062023-07-20
04719884330221H&HSH0505SH05052023-07-20
04719884330207H&HSH2106SH21062023-07-20
04719884331402H&HWG0030WG00302023-07-20
04719859641932H&HHW2106HW21062020-06-12
04719859641949H&HHW1206HW12062020-06-12
04719859641956H&HHW0505HW05052020-06-12
04719859642014H&HSH1206SH12062020-06-12
04719859642021H&HSH0505SH05052020-06-12
04719859642007H&HSH2106SH21062020-06-12

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