FDA.report

H&H

Primary DI
04719859642007
Brand
H&H
Company
TRONJEN MEDICAL TECHNOLOGY INC.
Model
SH2106
Catalog number
SH2106
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

Product Codes

CodeName
NADDressing, Wound, Occlusive

Product Code Classifications

CodeDeviceSpecialtyClass
NADDressing, Wound, OcclusiveGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04719859642007PackageGS16In Commercial Distribution
04719859642052PrimaryGS10

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
Length21Centimeter
Width6Centimeter

Sterilization Methods

Method
Radiation Sterilization

Contacts

PhoneEmail
4085411393vera@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 DIBrandModelCatalogPublished
04719884330269H&HSC21062025-12-12
04719884330368H&HSC21062025-12-12
04719884333765H&HSG00072025-12-11
04719884330139H&HHW2106HW21062023-07-20
04719884330146H&HHW1206HW12062023-07-20
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

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