FDA.reportPublic FDA data

H&H

Primary DI
04719859642045
Brand
H&H
Company
TRONJEN MEDICAL TECHNOLOGY INC.
Model
SH0505
Catalog number
SH0505
Device description
Effective treatment for scar1. Maintain proper moist environment2. Support and close the wound3. Tissue well arrayed, reduce scar proliferation.
Published
2020-06-12
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NADDressing, Wound, Occlusive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NADDressing, Wound, OcclusiveGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04719859642021PackageGS112Not in Commercial Distribution
04719859642045PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719859642021047198596420214719859642021
04719859642045047198596420454719859642045

GMDN Terms#

Term, Definition table
TermDefinition
Scar-management dressing, single-useA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length5Centimeter
Width5Centimeter

Sterilization Methods#

Method table
Method
Radiation Sterilization

Contacts#

Phone, Email table
PhoneEmail
4085411393vera@ad-surgical.com

Regulatory Flags#

DUNS number
657496877
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04719884330269H&HSC21062025-12-12
04719884330368H&HSC21062025-12-12
04719884333765H&HSG00072025-12-11
04719859641918H&HHW1206HW12062020-06-12
04719859642038H&HSH1206SH12062020-06-12
04719859641925H&HHW0505HW05052020-06-12
04719859641901H&HHW2106HW21062020-06-12
04719859642052H&HSH2106SH21062020-06-12
04719884330108H&HHW2106HW21062023-07-20
04719884330115H&HHW1206HW12062023-07-20
04719884330122H&HHW0505HW05052023-07-20
04719884330238H&HSH1206SH12062023-07-20
04719884330245H&HSH0505SH05052023-07-20
04719884330252H&HSH2106SH21062023-07-20
04719884330139H&HHW2106HW21062023-07-20
04719884330146H&HHW1206HW12062023-07-20
04719884330153H&HHW0505HW05052023-07-20
04719884330214H&HSH1206SH12062023-07-20
04719884330221H&HSH0505SH05052023-07-20
04719884330207H&HSH2106SH21062023-07-20

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Primary DI, Brand, Company table
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00850087488396CeeportCEEPORT INC.NAD2026-05-29
00850087488402CeeportCEEPORT INC.NAD2026-05-29
00850087488419CeeportCEEPORT INC.NAD2026-05-29
10840330701560ProCureTwin Med, LLCNAD2026-04-28
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10840330701621ProCureTwin Med, LLCNAD2026-04-28
10840330701638ProCureTwin Med, LLCNAD2026-04-28
10840330701645ProCureTwin Med, LLCNAD2026-04-28
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10840330701669ProCureTwin Med, LLCNAD2026-04-28
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10735471024695PolyMemFERRIS MFG. CORP.NAD2026-01-14
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10192253038811KendallCardinal Health 200, LLCNAD2025-11-21