FDA.reportPublic FDA data

DermaAngel Active Patch Original

Primary DI
04719745108518
Brand
DermaAngel Active Patch Original
Company
BENQ MATERIALS CORP.
Model
AP-361-8
Device description
No description.
Published
2022-09-21
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
NACDressing, Wound, Hydrophilic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NACDressing, Wound, HydrophilicGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04719745108563PackageGS151In Commercial Distribution
04719745108518PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719745108563047197451085634719745108563
04719745108518047197451085184719745108518

GMDN Terms#

Term, Definition table
TermDefinition
Exudate-absorbent dressing, non-gel, non-antimicrobialA wound covering intended to assist in wound healing by absorbing exudate in wounds (e.g., ulcers, burns, surgical wounds, lacerations, abrasions) and often by creating a moist wound-healing environment. It is not in the form of a gel and does not produce a water-absorbent gel upon contact with wound exudates, but may be designed to absorb and remove exudates (e.g., by capillary action); it does not contain an antimicrobial agent, but may include antioxidant properties. The device is available in a variety of forms (e.g., flat sheet/film-like, impregnated pouches, filled sachets, lyophilized matrix, ribbon, rope, foam, liquid, or powder). After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
657476292
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04719745027055DermaAngel Acne patchAP-362-c2022-09-21
04719745040429DermaAngel Acne patchAP-361-42022-09-21
04719745053085DermaAngel Acne patchAP-341-52022-09-21
04719745053580DermaAngel Acne patchAP-3c1-j2022-09-21
04719745072628DermaAngel Acne patchAP-361-62022-09-21
04719745108525DermaAngel Active Patch Original AP-391-j2022-09-21
04719745108532DermaAngel Active Patch Original AP-391-82022-09-21
04719745108549DermaAngel Active Patch IntensiveAP-SA151-f2022-09-21
04719745108556DermaAngel Active Patch IntensiveAP-SA151-p2022-09-21
04719745077562DermaAngel Clear Patch OriginalAP-361-c2023-10-11
04719745106682DermaAngel Clear Patch IntensiveAP-SA151-82025-06-24
04719745091568Ameda ComfortGel Hydrogel Pads17261M2025-01-21
04719745091551DermaAngel Clear Patch IntensiveAP-SA1i1-s2024-08-06
04719745053450DermaAngel Clear Patch OriginalAP-361-32024-07-08
04719745073793DermaAngel Clear Patch IntensiveAP-SA151-62024-07-08
04719745088803DermaAngel Clear Patch IntensiveAP-SA1i1-t2024-07-08
04719745088810DermaAngel Clear Patch IntensiveAP-SA1l1-f2024-07-08
04719745088827DermaAngel Clear Patch IntensiveAP-SA1y1-h2024-07-08
04719745074158DermaAngel Clear Patch IntensiveAP-SA101-22024-06-04
04719745086168DermaAngel Clear Patch OriginalAP-361-42024-06-04

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Primary DI, Brand, Company table
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