FDA.reportPublic FDA data

Medifoam

Primary DI
08806129660093
Brand
Medifoam
Company
Genewel Co.,Ltd.
Model
12NL02
Device description
Medifoam is indicated for the management of exuding wounds such as ulcers, burns, surgical/traumatic/acute, lacerations, abrasions, etc. It readily absorbs exudate, providing a moist wound interface that produces an optimal wound healing environment. To help adhesion, a non-woven fabric for fixation is enclosed with the product. Medifoam is a sterile, but Non-woven fabric is a non-sterile. This is single-use product, do not re-use. This product does not include a hydrophilic wound dressing that contains added drugs such as antimicrobial agents, added biologics such as growth factors, or is composed of materials derived from animal sources.
Published
2022-10-30
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

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
08806129660031PrimaryGS10
08806129660093Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806129660031088061296600318806129660031
08806129660093088061296600938806129660093

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
987669599
Device count
3
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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08806129660185Medifoam12NJ052025-03-03
08806129660208Medifoam bandMBD03401512025-03-03
08806129660222Medifoam H band MediumMB291303M2025-03-03
08806129660239Medifoam H band MediumMB291303M2025-03-03
08806129660253Medifoam H band largeMB352003L2025-03-03
08806129660260Medifoam H band largeMB352003L2025-03-03
08806129660178Medifoam12NJ052025-03-03
08806129660192Medifoam bandMBD03401512025-03-03
08806129660215Medifoam H band MediumMB291303M2025-03-03
08806129660246Medifoam H band largeMB352003L2025-03-03
08806129660109Medifoam HML100100032022-11-30
08806129660000Medifoam HML100100032022-10-30
08806129660031Medifoam12NL022022-10-30
08806129660147Medifoam H beautyMVmix12022-10-30
08806129660161Medifoam H bandMB2513032022-10-30
08806129660048Medifoam HML100100032022-10-30
08806129660055Medifoam H beautyMVmix12022-10-30
08806129660062Medifoam H bandMB2513032022-10-30

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Primary DI, Brand, Company table
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04260223630347curea P2curea medical GmbHNAC2026-09-27
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04260223631757curea P1 DUO activecurea medical GmbHNAC2026-09-27
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