FDA.reportPublic FDA data

Anscare Hydrocolloid Dressing(Sterile)

Primary DI
04719745008238
Brand
Anscare Hydrocolloid Dressing(Sterile)
Company
BENQ MATERIALS CORP.
Model
HS-330-2
Device description
Anscare Hydrocolloid Dressings(Sterile) are hydrophilic, occlusive dressings. The flexible outer layer helps isolate the wound against bacterial and other external contamination while the dressing remains intact without leakage. The inner layer maintains a moist wound environment while absorbing excess wound exudate to prevent fluid pooling.
Published
2022-09-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
NAEDressing, Wound, Hydrogel Without Drug And/Or Biologic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NAEDressing, Wound, Hydrogel Without Drug And/Or BiologicGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04719745008238PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719745008238047197450082384719745008238

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
04719745108518DermaAngel Active Patch Original AP-361-82022-09-21
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

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Primary DI, Brand, Company table
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10840330706350ProCureTwin Med, LLCNAE2026-04-22
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10197344110162MEDLINEMEDLINE INDUSTRIES, INC.NAE2025-08-04
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00810040134692SimpuritySAFE N' SIMPLE LLCNAE2025-06-17
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