FDA.report

H&H

Primary DI
04719884330153
Brand
H&H
Company
TRONJEN MEDICAL TECHNOLOGY INC.
Model
HW0505
Catalog number
HW0505
Device description
Hydration healing for wounds 1. absorbing exudate (reduce the number of dressing changes, to avoid interference with woundhealing) 2. Non-adherent and Non-linting (Easy to remove, won’t cause wound trama) 3. Perfect conformity (Conform to wound’sfigure 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
04719884330153PackageGS16In Commercial Distribution
04719884330320PackageGS1144In Commercial Distribution
04719859641925PreviousGS10
04719884330122PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04719884330153047198843301534719884330153
04719884330320047198843303204719884330320
04719859641925047198596419254719859641925
04719884330122047198843301224719884330122

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
Length5Centimeter
Width5Centimeter

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
04719884330146H&HHW1206HW12062023-07-20
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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